- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07317024
Additional Effects of Shockwave Therapy Along With Median Nerve Gliding Exercises in Patient With Carpal Tunnel Syndrome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVE:
The objectives of this study are:
- To evaluate and compare the effects of shockwave therapy combined with nerve gliding exercises against nerve gliding exercises alone on the velocity and amplitude of the median nerve.
- To analyze and compare the impact of shockwave therapy combined with nerve gliding exercises versus nerve gliding exercises alone on hand function in individuals with carpal tunnel syndrome.
- To assess and compare the effects of shockwave therapy combined with nerve gliding exercises with those of nerve gliding exercises alone on reported pain levels.
HYPOTHESIS
Alternate Hypothesis:
There will be statistically significant difference in effects of shockwave therapy combined with nerve gliding exercises and in comparison to nerve gliding exercises alone on hand functional strength, velocity and amplitude of the median nerve and pain. . (p<0.05).
Null Hypothesis:
There will be no statistically significant difference in effects of shockwave therapy combined with nerve gliding exercises and in comparison to nerve gliding exercises alone on hand functional strength, velocity and amplitude of the median nerve and pain. (p<0.05).
Research Design: Experimental study. Randomized Control Trial
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Gender: Both females and males were included.
- Age: Between 20 and 40 years old.
- Patients exhibiting positive results on the "Phalen's test and Tinel's test."
- Presence of symptoms, including pain, tingling and numbness, affecting the first, second and third fingers.
Exclusion Criteria:
- Individuals with a history of wrist surgery.
- Patients with active infections or cancer, for whom shockwave therapy is contraindicated.
- Pregnant females.
- Individuals diagnosed with rheumatoid arthritis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: INTERVENTIONAL GROUP B- SHOCKWAVE THERAPY WITH NERVE GLIDING
The participants will recieve 3 minutes of Shockwave therapy along with nerve gliding exercises thrice a week for 4 weeks with total 30 minutes sessions. Intensity of exercise will be incresed gradually and according to patient progress with break time to avoid fatigue. The intensity of the shock waves is set at 0.03 mJ/mm².The applied pressure is around 1.6 bar. Each session involves deliver in 2000 shocks. Shockwave therapy will targeted at the area between the thenar and hypothenar eminences on the palm |
Shockwave therapy is a physical intervention intended for diverse musculoskeletal disorders.
There are two primary categories: targeted extracorporeal shockwave therapy (ESWT) and radial shockwave therapy.
The two approaches vary in their generation, characteristics, and impact.
Extracorporeal Shock Wave Therapy (ESWT) is generated in water via electrohydraulic, electromagnetic, or piezoelectric sources.
This technique generates a concentrated pressure field that converges at a profound focal point, yielding maximum pressure.
Conversely, radial shockwaves are produced by propelling a projectile through an air-compressed tube, resulting in a diverging pressure field that affects the tissue more superficially.
ESWT in carpal tunnel syndrome (CTS) have reported enhancements in symptoms, functional scores and pain levels.
Additionally, low-to-moderate intensity ESWT has been shown to have positive effects on nerve conduction studies.
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Active Comparator: CONTROL GROUP A- CONVENTIONAL PHYSICAL THERAPY
The participants will perform nerve gliding exercises in which hand and wrist will moved through six more positions to mobilize the median nerve. Subjects will recieve protocal of 30 mins thrice a week for 4 weeks with 2 min rest in between. The exercises will focus on mobility of median nerve and reduce compression related symptoms to improve function and strength. |
Median nerve mobilization involves exercises aimed at relieving pressure in the carpal tunnel, making it a common treatment for carpal tunnel syndrome (CTS).
Techniques may stretch the nerve from both ends or apply tension to one end while releasing the other.
Some techniques stretch the nerve from both ends at the same time, while others apply tension to one end while allowing the other end to relax.
Conservative treatment options include Neurodynamic mobilization, which utilizes neural gliding to promote nerve movement in relation to surrounding musculoskeletal tissues.
This biomechanical strategy aims to decrease swelling and adhesions within the carpal tunnel, thereby restoring the nerve's mobility.
Studies have also reported neuromodulatory effects from neural mobilization techniques due to the chronic nature of CTS.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Pain Level
Time Frame: 4 weeks
|
The Numeric Pain Rating Scale (NPRS) is a patient-reported measure of pain intensity, with lower scores indicating less pain. Scores between 0-1 indicate minimal pain, generally with little to no interference in daily life. Mild pain, characterized by scores of 2-3. A score in the 4-6 range signifies moderate pain, which is noticeable, can interfere with specific daily functions. Finally, severe pain, represented by scores of 7-10, is intense. |
4 weeks
|
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Hand Movement and Function
Time Frame: 4 weeks
|
Functional Status Scale (BCFSS) measures the difficulty patients experience with performing specific daily activities affected by CTS, also often on a 1-5 point scale, where higher scores reflect greater functional limitation.
Lower scores mean better hand function.
Scores around 1.0-2.0
indicate mild impact, 2.0-3.0 moderate impact, and above 3.0 severe impact.
|
4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Carpal Tunnel Syndrome
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Ultrasonic Therapy
- Diathermy
- Hyperthermia, Induced
- Extracorporeal Shockwave Therapy
Other Study ID Numbers
- FUI/CTR/2025/11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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