The Effectiveness of Physical Therapy Modalities in Carpal Tunnel Syndrome

February 17, 2017 updated by: Małgorzata Eliks, Poznan University of Medical Sciences

The Effects of Nerve and Tendon Gliding Exercises Combined With Low-level Laser or Ultrasound Therapy in Carpal Tunnel Syndrome

Carpal tunnel syndrome is considered to be the most common entrapment neuropathy. Conservative treatment is recommended in the mild and moderate stage of CTS. The aim of this trial is to evaluate the effectiveness of physical therapy modalities in carpal tunnel syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Conservative treatment is recommended in the mild and moderate stage of CTS and should involve splinting, steroid injections, oral steroids and ultrasounds .

However, the results of some research studies have showed the beneficial effect of photobiomodulation as well as nerve and tendon gliding exercises in non-operative treatment .

Patients were divided into two groups. The one group received low-level laser therapy (LLLT); the other group underwent ultrasound treatment. Additionally, nerve and gliding exercises were administered in both groups.

The purpose of this trial is to assess the therapeutic efficacy of ultrasound treatment and low-level laser therapy combined with nerve and tendon gliding exercises and to compare the two regimens.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Poznan, Poland, 61-701
        • Poznan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of the mild or moderate stage of CTS, symptom duration for more than three months and general good health

Exclusion Criteria:

  • advanced CTS, secondary CTS, any previous surgery in the upper limb, steroid injections and any physical therapy treatment within six months prior to the study, pregnancy, cervical radiculopathy, peripheral polyneuropathy or other neurological conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group with low-level laser treatment

The group received low-level laser therapy (LLLT). The application of a GaAlAs infrared laser with a pencil probe (BTL 5000 Combi, United Kingdom; at 830 nm, 9J/cm2 per point, power output of 100 mW, beam diameter of 5 mm) was performed at five points along the median nerve on the palmar side of the wrist 7. The time of exposure was 10 minutes (2 minutes per point). Both the patient and the therapist wore protective glasses during every session.A total of 10 therapeutic sessions were performed during a period of two weeks (five session times per week).

Additionally, nerve and gliding exercises were administered.
Other: Low-level laser therapy
Active Comparator: Group with ultrasound treament
The group underwent ultrasound treatment. Ultrasound treatment was administered at a frequency of 1 MHz, intensity of 1 W/cm2 ,pulsed mode duty cycle of 1:4 and with a handhold transducer of 5 cm2 (BTL 5000 Combi, UK). The time of application was 6 minutes over the area of the carpal tunnel. Aquasonic gel was used as a couplant. A total of 10 therapeutic sessions were performed during a period of two weeks (five session times per week). Additionally, nerve and gliding exercises were administered.
Other: Ultrasound treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The measurement of hand grip strength in patients with carpal tunnel syndrome after physical therapy
Time Frame: 14 days
The Jamar dynamometer (Sammons Preston, Canada) is used to assess hand grip strength; the mean score of three consecutive trials is accepted for each strength measurement. The result is expressed in kilogram [kg]. The evaluation is performed before and after treatment.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Study Director: Małgorzata Zgorzalewicz-Stachowiak, PhD, Poznan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2009

Primary Completion (Actual)

February 15, 2014

Study Completion (Actual)

November 12, 2016

Study Registration Dates

First Submitted

February 14, 2017

First Submitted That Met QC Criteria

February 17, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1029/08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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