Radial Extracorporeal Shock Wave Therapy in the Treatment of Carpal Tunnel Syndrome

NCT04416867 | Completed

• 1 other identifier: 2020/10-106
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

Carpal tunnel syndrome (CTS) is the most common of all entrapment syndromes with a prevalence of 1-5%. Electrodiagnostic testing is used to make a definite diagnosis. The mainstay of the pathophysiology of CTS includes mechanical damage to the median nerve due to build up of pressure in the carpal tunnel and nerve ischaemia. Physical therapy (PT) in particular is the conventional non-surgical treatment of choice in the management of mild to moderate CTS, resulting in pain reduction and improved function. Extracorporeal shock wave therapy (ESWT) is a non invasive treatment method in which high frequency sound waves are applied to the body. The mechanism of action of ESWT in the treatment of CTS remains largely unknown. Eventhough there are many therapeutic options in the treatment of mild to moderate CTS, there is no consensus on the most effective treatment (4). ESWT has become a desirable treatment option in recent years. However, due to small patients numbers in trials to date and a lack of placebo controlled studies, the efficacy of this treatment option is still under debate. This study aims to compare the efficacy of RESWT to the recommended conventional PT modalities, including therapeutic US, in the treatment of CTS with regards to nociceptive and neuropathic pain, functionality and nerve conduction study outcomes.

Conditions

Carpal Tunnel Syndrome

Keywords

Extracorporeal shock wave therapy; Carpal Tunnel Syndrome; physical therapy

Outcome Measures

Primary Outcomes (1)

• The Boston carpal tunnel questionnaire (BCTQ)

  This questionnaire determines symptom severity (BCTQs) and functional outcome (BCTQf) specific to CTS using a scale for each. BCTQs is determined using 11 questions each with 5 answers to choose from scored from 1 to 5 giving a BCTQs total out of 55. The higher the score the greater the symptom severity. BCTQf questions the difficulty of 8 functional activities scored from 1 to 5 giving a BCTQf total out of 40. The higher the score the worse the functional capacity

  Change from Baseline BCTQ at 3 weeks post-treatment

Secondary Outcomes (2)

• Visual analogue scale (VAS)

  Change from Baseline VAS at 3 weeks post-treatment

• Leeds Assesment of Neuropathic Symptoms and Signs (LANSS)

  Change from Baseline LANSS at 3 weeks post-treatment

Study Arms (3)

group-1 splint and home exercise

ACTIVE COMPARATOR

Patients in group 1 will be treated with splinting of the affected hand at night and a home exercise program. A wrist orthosis which held the wrist in the neutral position will be used for splinting at night time for a minimum of eight hours. Each patient will be given a home exercise program of wrist range of motion, wrist stretch, wrist isometric strengthening and median nerve glide exercises to be performed daily for the duration of the study

Device: splint and home exercise

group 2 RESWT

ACTIVE COMPARATOR

Patients in group 2 will be treated with splinting of the affected wrist at night, a home exercise program similar to that of group one and a total of 3 sessions of RESWT at a frequency of one session per week using the Masterpuls ® mp200 radial shock wave therapy system (Elite-Storz Medical AG, Kreuzlingen, Switzerland). RESWT at a pressure of 4 bars, a frequency of 5Hz and 2000 hits in total will be applied 2cm proximal to the median nerve, with the probe directed towards the palm, diffusely over the pisiform.

Device: RESWT

group 3 physical therapy

ACTIVE COMPARATOR

Patients in group 3 will be treated with splinting of the affected wrist at night, a home exercise program similar to that of group one and two and 20 minutes of liquid paraffin treatment of the hand, 1.5watt/cm2 therapeutic ultrasound applied to the volar surface of the wrist for 5 minutes and 20 minutes of transcutaneous electrical nerve stimulation (TENS) on five consecutive days of the week for a total of fifteen sessions over 3 weeks.

Device: physical therapy

Interventions

splint and home exercise DEVICE

Each patient will be given a home exercise program of wrist range of motion, wrist stretch, wrist isometric strengthening and median nerve glide exercises to be performed daily for the duration of the study

group-1 splint and home exercise

RESWT DEVICE

RESWT at a pressure of 4 bars, a frequency of 5Hz and 2000 hits in total will be applied 2cm proximal to the median nerve, with the probe directed towards the palm, diffusely over the pisiform.

Also known as: splint and home exercise

group 2 RESWT

physical therapy DEVICE

20 minutes of liquid paraffin treatment of the hand, 1.5watt/cm2 therapeutic ultrasound applied to the volar surface of the wrist for 5 minutes and 20 minutes of transcutaneous electrical nerve stimulation (TENS) on five consecutive days of the week for a total of fifteen sessions over 3 weeks

Also known as: splint and home exercise

group 3 physical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have symptoms of CTS for more than three months with physical examination and electrophysiological findings consistent with mild to moderate CTS

You may not qualify if:

• Presence of other sensory or motor neuropathies
• History of surgery, trauma or fracture of the index hand and wrist
• History of corticosteroid injection or PT of the index wrist within the past three months.

Sponsors & Collaborators

• Erzurum Regional Training & Research Hospital: lead

Study Sites (2)

Baskent University

Ankara, Turkey (Türkiye)

Location

Erzurum Regional Training & Research Hospital

Erzurum, Turkey (Türkiye)

Location

Related Publications (3)

• Kim JC, Jung SH, Lee SU, Lee SY. Effect of extracorporeal shockwave therapy on carpal tunnel syndrome: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Aug;98(33):e16870. doi: 10.1097/MD.0000000000016870.

  PMID: 31415424 BACKGROUND

• Vahdatpour B, Kiyani A, Dehghan F. Effect of extracorporeal shock wave therapy on the treatment of patients with carpal tunnel syndrome. Adv Biomed Res. 2016 Jul 29;5:120. doi: 10.4103/2277-9175.186983. eCollection 2016.

  PMID: 27563630 BACKGROUND

• Paoloni M, Tavernese E, Cacchio A, D'orazi V, Ioppolo F, Fini M, Santilli V, Mangone M. Extracorporeal shock wave therapy and ultrasound therapy improve pain and function in patients with carpal tunnel syndrome. A randomized controlled trial. Eur J Phys Rehabil Med. 2015 Oct;51(5):521-8. Epub 2015 Feb 20.

  PMID: 25697763 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Splints; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Therapeutics; Rehabilitation

Study Officials

• Gonca Saglam, MD

  Erzurum Regional Traning and

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All pre and post study evaluations will be performed by a single physical medicine and rehabilitation specialist blind to the patients' treatment groups. Patients will be randomised into the groups by a second physical medicine and rehabilitation specialist. PT wil be conducted by a single experienced physiotherapist. All data analysis will be conducted by a PMR specialist blind to the treatment provided.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical medicine and rehabilitation department

Model Details: This study aims to compare the efficacy of RESWT to the recommended conventional PT modalities, including therapeutic US, in the treatment of CTS with regards to nociceptive and neuropathic pain, functionality and nerve conduction study outcomes.

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: January 1, 2020
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: March 23, 2022

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data that underlie the results reported in this article, after identification (text,tables,figures) will be made available
• Access Criteria: The data will be shared with researchers providing a methodologically sound proposal. Proposals should be directed to goncasaglam@hotmail.com. To gain access , data requestors will need to sign a data access agreement. Data will be accessible for a period of one year.

Locations

TU (2)