Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000666325
Ethics application status
Approved
Date submitted
19/02/2017
Date registered
8/05/2017
Date last updated
8/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of deep tissue massage and therapeutic massage for lower back pain, disease activity and functional capacity of Ankylosing Spondylitis patients: a randomized controlled trial.
Scientific title
Effectiveness of deep tissue massage and therapeutic massage for lower back pain, disease activity and functional capacity of Ankylosing Spondylitis patients: a randomized controlled trial.
Secondary ID [1] 291219 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ankylosing spondylitis (AS) 302138 0
Condition category
Condition code
Musculoskeletal 301750 301750 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 301978 301978 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Deep tissue massage: the massage therapist gave a series of 10 back massages intended to identify and alleviate musculoskeletal contributors to the participants' lower back pain. It was performed by using trigger point therapy and oblique pressure for a combination of lengthening strokes (extending a particular joint while at the same time working the muscle in the direction of the lengthening), Cross-fibre strokes (rolling the fingers over the tendon or muscle, back and forth, perpendicular to the fibre direction for two or three minutes), anchor and stretch (anchoring at a tight area and stretching away from the spot), freeing muscle from entrapment (mobilizing the erector spinae muscle in the lateral/medial direction by using both fingers of both hands to apply force along the border of the muscle and slowly push the muscle towards the opposite side).

Patients from both groups: DTM (deep tissue massage) and TM (therapeutic massage) underwent 30-minute session of deep tissue massage or therapeutic massage daily for 2 weeks (total of 10 sessions). Massage was provided by 2 licensed therapists with at least 5 years of experience who were comfortable following the study protocol and had experience in the permitted techniques.
Intervention code [1] 297222 0
Rehabilitation
Intervention code [2] 297426 0
Treatment: Other
Comparator / control treatment
Therapeutic massage: the massage therapist gave a series of 10 back massages (from sacrum to occipital bone) intended to ease lower back pain and improve function by inducing a generalized sense of relaxation. Five distinct techniques were permitted: effleurage (gliding), petrissage (kneading, rolling), friction, holding, vibration.

Patients from both groups: DTM (deep tissue massage) and TM (therapeutic massage) underwent 30-minute session of deep tissue massage or therapeutic massage daily for 2 weeks (total of 10 sessions). Massage was provided by 2 licensed therapists with at least 5 years of experience who were comfortable following the study protocol and had experience in the permitted techniques.
Control group
Active

Outcomes
Primary outcome [1] 301150 0
The Bath Ankylosing Spondylitis Disease Activity (BASDAI), Total score is based on every answer of BASDAI questions.
Timepoint [1] 301150 0
assessment occurs post treatment (total of 10 sessions) .
It will be done one day after the treatment is over.
Primary outcome [2] 301151 0
Bath Ankylosing Spondylitis Functional Index (BASFI) . Total score is based on every answer of BASFI questions.
Timepoint [2] 301151 0
assessment occurs post treatment (total of 10 sessions) .
It will be done one day after the treatment is over.
Secondary outcome [1] 331871 0
Modified Schober Test
Timepoint [1] 331871 0
assessment occurs post treatment (total of 10 sessions) .
It will be done one day after the treatment is over.
Secondary outcome [2] 331872 0
Chest expansion (CE), Measurement of chest wall can be measured with the use of measure
tap which is Universally approved which gives true measurement of chest wall Normally,
a 2-5" of chest expansion can be observed
Timepoint [2] 331872 0
assessment occurs post treatment (total of 10 sessions) .
It will be done one day after the treatment is over.

Eligibility
Key inclusion criteria
Diagnosis of AS
Age range: 20-60 years old
Informed consent for participation in the study, signed by the patient
Minimum age
20 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Pain (NRS) < 4 points
Change in dosage of non-steroidal anti-inflammatory drugs and corticosteroids for 2 weeks before the beginning of the study and for the duration of the study
Change in dosage of the disease-modifying antirheumatic drugs (methotrexate, sulfasalazine) for 3 months before the beginning of the study and for the duration of the study
Injection of a local anesthetic, steroids
Patients after surgical procedures around spine or in the abdominal area
Neurological signs present
Compression of spinal nerve root confirmed by specific imaging techniques: computed tomography, myelography, or magnetic resonance imaging

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)
The procedure of randomization was carried out using unmarked envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling.
After baseline assessments, male patients will be randomly assigned to Group DTM (deep tissue massage) and Group TM (therapeutic massage). The procedure of randomization will carry out using unmarked envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
The data distribution was assessed by the Shapiro-Wilk test. As data was not normally distributed, the comparisons between the two groups were assessed by the Mann-Whitney test. For paired variables, the Wilcoxon test was used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/05/2017
Actual
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
13/07/2017
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 8677 0
Poland
State/province [1] 8677 0
Wielkopolska

Funding & Sponsors
Funding source category [1] 295669 0
University
Name [1] 295669 0
Poznan University of Medical Sciences, Poland
Country [1] 295669 0
Poland
Primary sponsor type
University
Name
Poznan University of Medical Sciences, Poland
Address
Poznan University of Medical Sciences, 28 Czerwca 1956 r. nr 135/147 St, 61-545 Poznan
Country
Poland
Secondary sponsor category [1] 294516 0
None
Name [1] 294516 0
Address [1] 294516 0
Country [1] 294516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296984 0
Bioethics Committee of the University of Medical Sciences in Poznan
Ethics committee address [1] 296984 0
Ethics committee country [1] 296984 0
Poland
Date submitted for ethics approval [1] 296984 0
02/06/2015
Approval date [1] 296984 0
11/06/2015
Ethics approval number [1] 296984 0
645/15

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

Contacts
Principal investigator
Name 72622 0
Dr Mateusz Wojciech Romanowski
Address 72622 0
Department of Rheumatology and Rehabilitation, Poznan University of Medical Sciences, 28 Czerwca 1956r. Str. 135/147
61-545 Poznan
Country 72622 0
Poland
Phone 72622 0
+48512046048
Fax 72622 0
Email 72622 0
[email protected]
Contact person for public queries
Name 72623 0
Mateusz Wojciech Romanowski
Address 72623 0
Department of Rheumatology and Rehabilitation, Poznan University of Medical Sciences, 28 Czerwca 1956r. Str. 135/147
61-545 Poznan
Country 72623 0
Poland
Phone 72623 0
+48512046048
Fax 72623 0
Email 72623 0
[email protected]
Contact person for scientific queries
Name 72624 0
Anna Straburzynska-Lupa
Address 72624 0
Poznan University School of Physical Education, Krolowej
Jadwigi 27/39, 61-871 Poznan, Poland
Country 72624 0
Poland
Phone 72624 0
+4861 835 51 58
Fax 72624 0
Email 72624 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.