NCT03061149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2014

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

4.9 years

First QC Date

February 14, 2017

Last Update Submit

February 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    14 days

Study Arms (2)

Group with low-level laser treatment

EXPERIMENTAL

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

Group with ultrasound treament

ACTIVE COMPARATOR

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

Interventions

Group with low-level laser treatment
Group with ultrasound treament

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 61-701, Poland

Location

Related Publications (6)

  • 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.

    PMID: 18754533BACKGROUND
  • 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.

    PMID: 9730093BACKGROUND
  • 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.

    PMID: 9529407BACKGROUND
  • 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.

    PMID: 1939356BACKGROUND
  • 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.

    PMID: 23543580BACKGROUND
  • 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.

    PMID: 21430512BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Małgorzata Zgorzalewicz-Stachowiak, PhD

    Poznan University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 23, 2017

Study Start

March 30, 2009

Primary Completion

February 15, 2014

Study Completion

November 12, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations