Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000367640
Ethics application status
Approved
Date submitted
25/03/2014
Date registered
7/04/2014
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of various methods of physiotherapy in the treatment of carpal tunel syndrome
Scientific title
Evaluation of the effectiveness of manual therapy, and neuromobilisation and laser and ultrasound in the treatment of carpal tunnel syndrome in patients with carpal tunel syndrome
Secondary ID [1] 284339 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carpal tunnel syndrome 291494 0
Condition category
Condition code
Neurological 291860 291860 0 0
Other neurological disorders
Musculoskeletal 291861 291861 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291915 291915 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The impact of the ten weeks treatment with use:

Arm 1. Manual therapy and Neuromobilisation - First Group
[Functional massage of the descending part of the trapezius (duration 3 min.). The 20 therapeutic sessions were performed twice a week.]
[Mobilization techniques described by Shacklock were used. Three series with 10 repetitions were used. The duration of one mobilisation was 15 s with a rest period of 10 s. Gliding and tension mobilisations of the median nerve were performed in the median neurodynamic test position (median neurodynamic test 1 – NM 1) with support. One-direction proximal and distal slider mobilisations and one-direction proximal and distal tension mobilisations were performed. The standard approach was to perform three series of 60 repetitions of glide and tension mobilisations. The duration of the inter-series intervals was 15s. The 20 therapeutic sessions were performed twice a week].

Arm 2. Laser and Ultrasound - Second group
[Laser therapy was performed using a contact method at three points on the palmar surface of the wrist in the transverse ligament area. Each procedure started with a red laser (using a R650/50 probe) emitting 658 nm light at 50 mW; the duration of biostimulation was 1 min 40s. The dose was 5J. Next, an infrared laser (with a IR810/400 probe) emitting 808 nm light at 400 mW was used; the duration of the biostimulation was 1 min. The dose was 24J. Thus, each point was stimulated for two minutes 40 s. The entire procedure was eight minutes long. 20 laser sessions were performed twice a week].
[Ultrasound therapy was used to treat the palmar surface of the hand in the transverse ligament area. The following parameters were used: frequency 1 MHz, intensity 1.0 W/ cm squared and impulse mode with a pulse width factor of 75%. Each procedure was 15 minutes long. 20 laser sessions were performed twice a week]

on Sensory conduction, Motor conduction, Motor
latency and other electrophysical modalities.
Intervention code [1] 289063 0
Treatment: Other
Intervention code [2] 289102 0
Rehabilitation
Comparator / control treatment
Two groups: Manual therapy and neural mobilisation (group 1 - experimental), laser and ultrasound therapy (group 2 - control).
Control group
Active

Outcomes
Primary outcome [1] 291772 0
Nerve conduction:
Examinations of nervous conduction was performed in the electromyography laboratory by experienced personnel. The examination was performed by an antidromic method using a Neuro-Mep instrument, with superficial electrodes.
Timepoint [1] 291772 0
Baseline and after therapy completion (10 weeks), and 1 month later post completion of therapy.
Primary outcome [2] 291773 0
Feeling two-point discrimination:
The examination of two-point discrimination sensation was performed with the use of its static variety by assessing innervation density in slowly adapting touch receptors. A standardised Dellon discriminator was used for the study.
Timepoint [2] 291773 0
Baseline and after therapy completion (10 weeks), and 1 month later post completion of therapy.
Primary outcome [3] 291775 0
Severity of pain:
A Numerical Pain Rating Scale (NPRS), which is a subjective method of pain evaluation by the patient, was used.
Timepoint [3] 291775 0
Baseline and after therapy completion (10 weeks), and 1 month later post completion of therapy.
Secondary outcome [1] 307507 0
Grip strength and diversification of kinesthetic force:
Dynamometer Jamar
Timepoint [1] 307507 0
Baseline and after therapy completion (10 weeks), and 1 month later post completion of therapy.
Secondary outcome [2] 307622 0
The range of movement and differentiation of kinesthetic movement:
Inclinometer Saunders
Timepoint [2] 307622 0
Baseline and after therapy completion (10 weeks), and 1 month later post completion of therapy.
Secondary outcome [3] 307623 0
Functional state:
Boston Carpal Tunnel Questionnaire
Functional Status Scale
Timepoint [3] 307623 0
Baseline and after therapy completion (10 weeks), and 1 month later post completion of therapy.
Secondary outcome [4] 307624 0
Self-assessment of health:
36 Health Survey Questionnaire
Timepoint [4] 307624 0
Baseline and after therapy completion (10 weeks), and 1 month later post completion of therapy.
Secondary outcome [5] 307625 0
modified phalen's test:
Phalen test
Timepoint [5] 307625 0
Baseline and after therapy completion (10 weeks), and 1 month later post completion of therapy.

Eligibility
Key inclusion criteria
Numbness and tingling in the area of the median nerve
Paraesthesia at night
Positive Phalen’s symptom
Positive Tinel’s symptom
Pain in the wrist area radiating to the shoulder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
earlier surgical treatment, steroid and non-steroid treatment, cervical radiculopathy, tendon sheath inflammation, rheumatoid diseases, diabetes, pregnancy, past traumas to the wrist, muscular atrophy of the thenar

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)
Patients were randomised by drawing lots with the group number. Individuals who drew the number “1” were assigned to the first group and those that drew number “2” were assigned to the second group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Each consecutive patient that was not excluded and that met the inclusion criteria was randomly assigned either to the neural mobilisation (NM - first group) or physical therapy (PT - second group) group. Patients were randomised by drawing lots with the group number. The persons that drew number ‘1’ were assigned to the NM group and those that drew number ‘2’ were assigned to the PT group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Student’s t-test; Chi2; An ANOVA model for analysis of variables with repeated measures. Analysis of variance was supplemented by the post hoc Bonferroni’s test. Mann-Whitney test; The critical p level was set at 0,05.
Based on the analysis of a power of the test on 20 patients demonstrated that to obtain a power of the test at 0.90 level, we need at least 90 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2007
Actual
3/09/2007
Date of last participant enrolment
Anticipated
10/12/2012
Actual
10/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 5928 0
Poland
State/province [1] 5928 0

Funding & Sponsors
Funding source category [1] 288972 0
University
Name [1] 288972 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 288972 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education
Address
Mikolowska 72A, 40-065 Katowice, Polska
Country
Poland
Secondary sponsor category [1] 287653 0
None
Name [1] 287653 0
Address [1] 287653 0
Country [1] 287653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290786 0
Bioethical Committee at The Jerzy Kukuczka Academy of Physical Education
Ethics committee address [1] 290786 0
Ethics committee country [1] 290786 0
Poland
Date submitted for ethics approval [1] 290786 0
Approval date [1] 290786 0
31/05/2007
Ethics approval number [1] 290786 0
16/2007

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

Contacts
Principal investigator
Name 47258 0
Dr Tomasz Wolny
Address 47258 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul. Mikolowska 72A, 40-065 Katowice
Country 47258 0
Poland
Phone 47258 0
+48 604820416
Fax 47258 0
Email 47258 0
[email protected]
Contact person for public queries
Name 47259 0
Pawel Linek
Address 47259 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul. Mikolowska 72A, 40-065 Katowice
Country 47259 0
Poland
Phone 47259 0
+48 661768601
Fax 47259 0
Email 47259 0
[email protected]
Contact person for scientific queries
Name 47260 0
Pawel Linek
Address 47260 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul. Mikolowska 72A, 40-065 Katowice
Country 47260 0
Poland
Phone 47260 0
+48 661768601
Fax 47260 0
Email 47260 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
SourceTitleYear of PublicationDOI
EmbaseEffect of manual therapy and neurodynamic techniques vs ultrasound and laser on 2PD in patients with CTS: A randomized controlled trial.2016https://dx.doi.org/10.1016/j.jht.2016.03.006
EmbaseEfficacy of Manual Therapy Including Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial.2017https://dx.doi.org/10.1016/j.jmpt.2017.02.004
EmbaseOverall health status in patients with mild to moderate carpal tunnel syndrome: A case-control study.2017https://dx.doi.org/10.1016/j.jht.2016.10.003
EmbaseThe Effect of Manual Therapy Including Neurodynamic Techniques on the Overall Health Status of People With Carpal Tunnel Syndrome: A Randomized Controlled Trial.2018https://dx.doi.org/10.1016/j.jmpt.2018.11.001
N.B. These documents automatically identified may not have been verified by the study sponsor.