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The Effectiveness of Physical Therapy Modalities in Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT03061149
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Małgorzata Eliks, Poznan University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Low-level laser therapy Other: Ultrasound treatment Not Applicable

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  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Nerve and Tendon Gliding Exercises Combined With Low-level Laser or Ultrasound Therapy in Carpal Tunnel Syndrome
Actual Study Start Date : March 30, 2009
Actual Primary Completion Date : February 15, 2014
Actual Study Completion Date : November 12, 2016


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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061149


Locations
Poland
Poznan University of Medical Sciences
Poznan, Poland, 61-701
Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
Study Director: Małgorzata Zgorzalewicz-Stachowiak, PhD Poznan University of Medical Sciences

Publications:
Responsible Party: Małgorzata Eliks, Assistant, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03061149     History of Changes
Other Study ID Numbers: 1029/08
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nerve Compression Syndromes
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries