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The Effectiveness of Physical Therapy Modalities in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Low-level laser therapy
Ultrasound treatment
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Poznan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group with low-level laser treatment

Group with ultrasound treament

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The measurement of hand grip strength in patients with carpal tunnel syndrome after physical therapy
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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2017
Last Updated
February 17, 2017
Sponsor
Poznan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03061149
Brief Title
The Effectiveness of Physical Therapy Modalities in Carpal Tunnel Syndrome
Official Title
The Effects of Nerve and Tendon Gliding Exercises Combined With Low-level Laser or Ultrasound Therapy in Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 30, 2009 (Actual)
Primary Completion Date
February 15, 2014 (Actual)
Study Completion Date
November 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group with low-level laser treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Group with ultrasound treament
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low-level laser therapy
Intervention Type
Other
Intervention Name(s)
Ultrasound treatment
Primary Outcome Measure Information:
Title
The measurement of hand grip strength in patients with carpal tunnel syndrome after physical therapy
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Małgorzata Zgorzalewicz-Stachowiak, PhD
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Poznan University of Medical Sciences
City
Poznan
ZIP/Postal Code
61-701
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18754533
Citation
Shooshtari SM, Badiee V, Taghizadeh SH, Nematollahi AH, Amanollahi AH, Grami MT. The effects of low level laser in clinical outcome and neurophysiological results of carpal tunnel syndrome. Electromyogr Clin Neurophysiol. 2008 Jun-Jul;48(5):229-31.
Results Reference
background
PubMed Identifier
9730093
Citation
Rozmaryn LM, Dovelle S, Rothman ER, Gorman K, Olvey KM, Bartko JJ. Nerve and tendon gliding exercises and the conservative management of carpal tunnel syndrome. J Hand Ther. 1998 Jul-Sep;11(3):171-9. doi: 10.1016/s0894-1130(98)80035-5.
Results Reference
background
PubMed Identifier
9529407
Citation
Ebenbichler GR, Resch KL, Nicolakis P, Wiesinger GF, Uhl F, Ghanem AH, Fialka V. Ultrasound treatment for treating the carpal tunnel syndrome: randomised "sham" controlled trial. BMJ. 1998 Mar 7;316(7133):731-5. doi: 10.1136/bmj.316.7133.731.
Results Reference
background
PubMed Identifier
1939356
Citation
Totten PA, Hunter JM. Therapeutic techniques to enhance nerve gliding in thoracic outlet syndrome and carpal tunnel syndrome. Hand Clin. 1991 Aug;7(3):505-20.
Results Reference
background
PubMed Identifier
23543580
Citation
Page MJ, O'Connor D, Pitt V, Massy-Westropp N. Therapeutic ultrasound for carpal tunnel syndrome. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD009601. doi: 10.1002/14651858.CD009601.pub2.
Results Reference
background
PubMed Identifier
21430512
Citation
Horng YS, Hsieh SF, Tu YK, Lin MC, Horng YS, Wang JD. The comparative effectiveness of tendon and nerve gliding exercises in patients with carpal tunnel syndrome: a randomized trial. Am J Phys Med Rehabil. 2011 Jun;90(6):435-42. doi: 10.1097/PHM.0b013e318214eaaf.
Results Reference
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The Effectiveness of Physical Therapy Modalities in Carpal Tunnel Syndrome

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