Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001574831
Ethics application status
Approved
Date submitted
24/11/2020
Date registered
18/11/2021
Date last updated
18/11/2021
Date data sharing statement initially provided
18/11/2021
Date results provided
18/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of manual versus electrical physiotherapy interventions in cervical myofascial pain syndrome in people with spinal injury.
Scientific title
Effectiveness of manual treatment versus electrotherapy treatment in cervical myofascial pain syndrome in spinal cord injury.
Secondary ID [1] 302854 0
Nil known
Universal Trial Number (UTN)
U1111-1261-6384
Trial acronym
Linked study record
No

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 319833 0
Cervical myofascial pain syndrome 319834 0
Physical disability 319837 0
Condition category
Condition code
Injuries and Accidents 317776 317776 0 0
Other injuries and accidents
Mental Health 317779 317779 0 0
Other mental health disorders
Musculoskeletal 317780 317780 0 0
Other muscular and skeletal disorders
Neurological 317781 317781 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 317782 317782 0 0
Physiotherapy
Public Health 317783 317783 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Intervention: Manual therapy

The manual therapy protocol was focused on the treatment of selected trigger points of the following muscles, in this particular order: right and left levator scapulae (upper-medial border trigger point), right and left trapezium upper fibers (central trigger point) and right and left sternocleidomastoid (apophysis mastoid insertional trigger point). Trigger points were identified by palpation and irradiated pain response according to Travel & Simons criteria.

Manual therapy protocol: Application of pressure release technique for three minutes for each muscle and side (six minutes in total), massage therapy for three minutes for each muscle and side (six minutes in total), and stretching for three minutes for each muscle and side (six minutes total). Each session took eighteen minutes in each muscle (ipsilateral and contralateral as a whole), adding up to a total of fifty-four minutes in the entire musculature. Preferentially, participants were at decubitus supine. Each participant received 12 sessions, twice a week on alternating days, until 1.5 months. The only material needed was almond oil to perform massage therapy intervention.

2. Additionally, during the manual therapy protocol (12 sessions), participants also received education intervention (see 2.1; 10 minutes during all 12 sessions) and a global/general intervention (see 2.2; 20 minutes per session during all 12 sessions after the manual therapy in a self-perceived moderate intensity in motoMED or bicicle).

2.1 Education: focused on a review of the importance of ergonomics, therapeutic exercise and physical activity. It consisted in two parts: the first, aimed at explaining ergonomics and exercises performance; the second, focused on the performance of the exercises (cervical movements, stretching, isometric/eccentric contractions) with supervision. The participants were encouraged to perform the exercises once a day when the whole MANUAL THERAPY and ELECTROTHERAPY interventions ended.

2.2 Global/general intervention: measures always considered in spinal cord injury (SCI) treatment, as free movements of extremities with motomed or bicycle, depending on the level of SCI. They took 20 minutes while performing the modality-dependent activities, but participants were able to enlarge if devices were available.

Total duration of the study: 11 months; 24 sessions (manual therapy + electrotherapy). While one group was receiving manual therapy, the other group received electrotherapy. After a resting period of 3.5 months, participants received the other intervention (crossed design).
Strategies used to monitor adherence: session attendance checklists.

All the interventions were face-to-face delivered by 4 experienced Physical therapist (minimum 5 years of experience) at the Centro Base de Personas con Discapacidad (Palma de Mallorca, Balearic Islands). All Physical therapist received face-to-face education about intervention procedures in 10 sessions along three months (between 12/2014-02/2015). Participants had to attend a 100% of MANUAL THERAPY and ELECTROTHERAPY sessions (12 + 12).
Intervention code [1] 319135 0
Rehabilitation
Intervention code [2] 319136 0
Lifestyle
Comparator / control treatment
Electrotherapy: Application of one-minute ultrasound (pulsatile (1:1), 1.5 W/cm2) for each muscle and side (two minutes in total), one-minute laser (pulsatile with pointer, between 4.2-5J/cm2) for each muscle and side (two minutes in total), and twenty-minutes TENS (low frequency, between 1-4Hz, with pulse duration between 150-300 microseconds and high intensity in tolerance limit with the negative electrode situated on the TRIGGER POINT) for each muscle and side applied simultaneously on both sides (twenty minutes total). Preferentially, participants were at decubitus supine. The electrical intervention took a total of twenty-four minutes, adding up to a total of seventy-two minutes in all the musculature. Devices used are described above:
US: Sonoplus 590 (Enraf Nonius)
Laser therapy: Laser IR 170 (Meditea)
TENS: Megasonic 313 (Electromedicarin)

Additionally, during the electrotherapy protocol (12 sessions), participants also received education intervention and a global/general as described above.

All the interventions were face-to-face delivered by 4 experienced Physical therapist (minimum 5 years of experience) at the Centro Base de Personas con Discapacidad (Palma de Mallorca, Balearic Islands). All Physical therapist received face-to-face education about intervention procedures in 10 sessions along three months (between 12/2014-02/2015). Participants had to attend a 100% of MANUAL THERAPY and ELECTROTHERAPY sessions (12 + 12).
Control group
Active

Outcomes
Primary outcome [1] 328754 0
Neck pain assessed using the numerical pain rating scale from 0 to 10
Timepoint [1] 328754 0
Pre-intervention, 1.5 weeks after intervention completion (primary endpoint), 3.5 months after the ending of each intervention in both protocols (Manual therapy and Electrotherapy)
Primary outcome [2] 328757 0
Neck pressure pain thresholds assessed using a surface algometry -F-Meter 5.0 STORZ Medical
Timepoint [2] 328757 0
Pre-intervention, 1.5 weeks after intervention completion (primary endpoint), 3.5 months after the ending of each intervention in both protocols (Manual therapy and Electrotherapy)
Primary outcome [3] 328763 0
Neck pain-related disability assessed using the Neck disability index
Timepoint [3] 328763 0
Pre-intervention, 1.5 weeks after intervention completion (primary endpoint), 3.5 months after the ending of each intervention in both protocols (Manual therapy and Electrotherapy)
Secondary outcome [1] 389182 0
Cervical range of motion (flexion, extension, rotations) assessed using a manual 20-cm goniometer -ENRAF NONIUS-.
Timepoint [1] 389182 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.
Secondary outcome [2] 389183 0
Physical disability assessed using the Spanish version of the Barthel index, which assesses 10 basic activities of daily living and gives a measure of functionality.
Timepoint [2] 389183 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.
Secondary outcome [3] 389184 0
Functional independence assessed using the Spanish version of the Spinal Cord Injury Measure Scale (SCIM), consisted on 17 questions distributed in three domains (self-care, breathing and toilet training, mobility).
Timepoint [3] 389184 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.
Secondary outcome [4] 389185 0
Disability assessed using the Spanish version of the Functional Independence measure (FIM), which assesses two domains (motor and cognitive) in seven categories and eighteen subcategories.
Timepoint [4] 389185 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.
Secondary outcome [5] 389186 0
Health status assessed using the Spanish version of the WHO Disability Assessment Schedule (WHO-DAS) consisted in six domains (understanding and communication; ability to move; personal care; relationships with others; activities of daily living; social participation).
Timepoint [5] 389186 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.
Secondary outcome [6] 389187 0
Self esteem assessed using the Spanish version of the Rosenberg self-esteem scale, consisted in 10 items rated with a 4-point Likert scale. It establishes three levels of self-esteem: normal/high, mean, low.
Timepoint [6] 389187 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.
Secondary outcome [7] 389188 0
Psychological status assessed using the Spanish version of the Beck’s Hopelessness Inventory, consisted in twenty questions assessing pessimism, hopelessness and risk of suicide.
Timepoint [7] 389188 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.
Secondary outcome [8] 389189 0
Quality of life assessed using the Spanish version of the Fast-espiditest, which is made up by four questions and six items. It establishes three levels of quality of life related to pain.
Timepoint [8] 389189 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.
Secondary outcome [9] 389190 0
Knowledge in ergonomics assessed by an exam designed ad hoc. The exam consisted in five questions, two points each (if correct but incomplete, it was scored with one point and if it was blank or incorrect, zero). Questions were the following:
a. Perform or explain an ergonomic transfer from chair to bed.
b. Explain how to stretch the following muscles: levator scapulae, upper-fiber trapezium and sternocleidomastoid.
c. Explain three rules of postural conditioning, ergonomics or home-adaptation.
d. Explain how muscle contractions should be to improve and avoid relapses.
e. Explain which kinds of adapted physical activity you know and which one you could practice according to your spinal cord injury level.
Timepoint [9] 389190 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.
Secondary outcome [10] 389191 0
Physical activity assessed using the Spanish version of the International Physical Activity Questionnaires (IPAQ), which establishes tree levels of physical activity (low or inactive, moderate, high).
Timepoint [10] 389191 0
Baseline, 1.5 weeks after intervention completion and 3.5 months after every intervention completion.

Eligibility
Key inclusion criteria
People with chronic spinal cord injury (American Society of Anesthesiologists ASIA equal to 1) aged between 20-60 years, diagnosed of bilateral cervical myofascial pain syndrome with active trigger points by a rehabilitating doctor, who signed informed consent and agreed to participate.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suffering from a traffic or work accident on the previous six months, pending on judgement or compensation.
Spinal cord injury level above C5 (injuries up to this level cause sensitive/motor affectation of studied muscles).
Ongoing oncological process.
Treatment with immunosuppressants
Higher engagement in physical activity than stipulated.
Psychiatric disorders.
Body mass index over 35.
Subjects who not complete the intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Free software: randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: considering the characteristics of the population and assuming an alpha risk of 0.05 and a beta risk under 0.20, for a bilateral contrast, with an expected loss to follow-up rate of 10%. Estimated sample size rated between 18 and 32 participants.

Moreover, all participants who went to the Physical therapy unit of the Service for Authonomy Promotion of the Balearic Islands (SEPAP) who met the inclusion criteria were encouraged to participate (n=30). From those, two declined to partake. Thus, almost all the population that met the inclusion criteria in Mallorca (n=28) accepted to participate.

Statistical methods:
Descriptive statistics (measures of central tendency, percentages of dispersion)
Non-parametric tests, Wilcoxon (due to sample size): to study treatment times for MT and ET (pre-/post- treatment / 3.5 months follow up)
Non-parametric tests, Wilcoxon (due to sample size): therapy effectiveness, by (1) short-term differences pre-/post- treatment with the same therapy (MT or ET); (2) long-term differences pre-/post- treatment with the same therapy (MT or ET); (3) Comparation of short versus long-term; (4) comparison between groups.
Spearman correlation coefficient: to relate in between the results of the different tests and questionnaires.
All comparisons used a signification level of 0.05.
All statistical analysis were performed with IBM SPSS statistics®, version 23.0.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2015
Date of last participant enrolment
Anticipated
Actual
18/01/2016
Date of last data collection
Anticipated
Actual
29/07/2016
Sample size
Target
30
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 23116 0
Spain
State/province [1] 23116 0
Balearic Islands

Funding & Sponsors
Funding source category [1] 307274 0
Self funded/Unfunded
Name [1] 307274 0
Miguel Angel Capó Juan
Country [1] 307274 0
Spain
Primary sponsor type
Individual
Name
Miguel Angel Capó Juan
Address
Servei de Valoració i Atenció Primerenca. Carrer Joan Maragall, 17-A, baixos – 07006
Conselleria d’Afers socials i Esport. Gobierno de las Islas Baleares. Palma de Mallorca. España.
Country
Spain
Secondary sponsor category [1] 307898 0
Individual
Name [1] 307898 0
Lucía Serna López
Address [1] 307898 0
Centro Base de Personas con Discapacidad. Servicio de Promoción de la Autonomía Personal de Palma de Mallorca. Dirección General de Dependencia. Consejería de Servicios Sociales y Cooperación. C/Joan Crespí 11, Palma, Illes Balears, 07013
Country [1] 307898 0
Spain
Secondary sponsor category [2] 307899 0
Individual
Name [2] 307899 0
Maria Magdalena Alzamora Perelló
Address [2] 307899 0
Centro Base de Personas con Discapacidad. Servicio de Promoción de la Autonomía Personal de Palma de Mallorca. Dirección General de Dependencia. Consejería de Servicios Sociales y Cooperación. C/Joan Crespí 11, Palma, Illes Balears, 07013
Country [2] 307899 0
Spain
Secondary sponsor category [3] 307900 0
Individual
Name [3] 307900 0
Rosa Maria Fiol Delgado
Address [3] 307900 0
Centro Base de Personas con Discapacidad. Servicio de Promoción de la Autonomía Personal de Palma de Mallorca. Dirección General de Dependencia. Consejería de Servicios Sociales y Cooperación. C/Joan Crespí 11, Palma, Illes Balears, 07013
Country [3] 307900 0
Spain
Secondary sponsor category [4] 307901 0
Individual
Name [4] 307901 0
Marta Bosch Gutiérrez
Address [4] 307901 0
Centro Base de Personas con Discapacidad. Servicio de Promoción de la Autonomía Personal de Palma de Mallorca. Dirección General de Dependencia. Consejería de Servicios Sociales y Cooperación. C/Joan Crespí 11, Palma, Illes Balears, 07013
Country [4] 307901 0
Spain
Secondary sponsor category [5] 307902 0
Individual
Name [5] 307902 0
Miquel Bennassar Veny
Address [5] 307902 0
Universitat de les Illes Balears, Carretera de Valldemossa, km 7.5, 07122 Palma, Illes Balears CIF: Q0718001A
Country [5] 307902 0
Spain
Secondary sponsor category [6] 307903 0
Individual
Name [6] 307903 0
Joan Ernest De Pedro Gómez
Address [6] 307903 0
Universitat de les Illes Balears, Carretera de Valldemossa, km 7.5, 07122 Palma, Illes Balears CIF: Q0718001A
Country [6] 307903 0
Spain
Secondary sponsor category [7] 307904 0
Individual
Name [7] 307904 0
Antoni Aguiló Pons
Address [7] 307904 0
Universitat de les Illes Balears, Carretera de Valldemossa, km 7.5, 07122 Palma, Illes Balears CIF: Q0718001A
Country [7] 307904 0
Spain
Secondary sponsor category [8] 307905 0
Individual
Name [8] 307905 0
Nuria Maria García Dopico
Address [8] 307905 0
Edificio S, Hospital Universitario Son Espases, Carretera de Valldemossa, 79, 07120 Palma, Balearic Islands.
Country [8] 307905 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307370 0
Comité de Ética de la Investigación de las Illes Balears
Ethics committee address [1] 307370 0
Ethics committee country [1] 307370 0
Spain
Date submitted for ethics approval [1] 307370 0
28/01/2015
Approval date [1] 307370 0
25/02/2015
Ethics approval number [1] 307370 0
IB 2479/15 PI

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106994 0
Dr Miguel Angel Capó Juan
Address 106994 0
Av. de Gabriel Alomar, 33 - 07006 Palma de Mallorca. Consejería de Servicios Sociales y Cooperación. Gobierno de las Islas Baleares. Palma de Mallorca. España.
Country 106994 0
Spain
Phone 106994 0
+34 971177685
Fax 106994 0
Email 106994 0
[email protected]
Contact person for public queries
Name 106995 0
Miguel Angel Capó Juan
Address 106995 0
Av. de Gabriel Alomar, 33 - 07006 Palma de Mallorca. Consejería de Servicios Sociales y Cooperación. Gobierno de las Islas Baleares. Palma de Mallorca. España.
Country 106995 0
Spain
Phone 106995 0
+34 971177685
Fax 106995 0
Email 106995 0
[email protected]
Contact person for scientific queries
Name 106996 0
Miguel Angel Capó Juan
Address 106996 0
Av. de Gabriel Alomar, 33 - 07006 Palma de Mallorca. Consejería de Servicios Sociales y Cooperación. Gobierno de las Islas Baleares. Palma de Mallorca. España.
Country 106996 0
Spain
Phone 106996 0
+34 971177685
Fax 106996 0
Email 106996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Mallorca is a small island and all participants who met the inclusion criteria were invited to participate (n=30). Due to the reduced sample size, it might be easy for the participants or their loved ones to know their identity only with anonymized data (level of injury, age, sex, years with spinal cord injury) so IPD will not be shared for ethical concerns. Moreover, data were collected on a public institution of the Balearic Islands and have to be available to further considerations or analysis.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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