- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855993
Neural Glides With and Without Therapeutic Ultra Sound on in Pregnant Computer Workers With Carpal Tunnel Syndrome
May 11, 2023 updated by: Riphah International University
Effects of Neural Glides With and Without Therapeutic Ultra Sound on Pain Symptom Severity and Functional Status in Pregnant Computer Workers With Carpal Tunnel Syndrome
To study the effects of Neural Glides with and without using therapeutic ultrasound and functional status in pregnant computer workers with CTS
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Carpal Tunnel Syndrome is a median nerve compression and results in significant discomfort and pain, daily living activity limitation, loss of sleep and work disability.
Carpal tunnel Syndrome is more common in pregnancy because in pregnancy prolactin hormone increase the fluid retention in extra capsule and results in soft tissue swelling.
Several therapeutically treatments have been advocated for the carpal tunnel syndrome including Mobilizations, nerve gliding, tendon gliding, Ultrasound, icing, Massaging.
Women experience pregnancy several times, and if they acquire Carpal tunnel syndrome, invasive treatments cannot be used, the probability of reoccurrence of Carpal tunnel syndrome in the next pregnancy with higher intensity.
Use of non-invasive treatment methods are more beneficial.
Carpal tunnel syndrome very common nowadays as most of the population is involved in computer work by some means especially the computer working ladies who always use the conventional mouse and key board for their work.
Pregnant Women diagnosed with Carpal Tunnel syndrome and are computer working would be selected for this study.
Diagnostic criteria would be positive Tinel's and Phalen's.
The subjects will be divided into two groups.
Group A (Experimental) and group B (Control).
Group A will perform with nerve glides with therapeutic ultrasound.
The control group does only exercise program (tendon and nerve gliding exercises).
Both groups are assessed by outcome measures pre and post interventions.
Pain symptoms is measured with the help of Visual Analogue Scale, The Boston Carpal Tunnel questionnaire form will administer for the patient evaluation Functional Status Scale and Symptom Severity Scale.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Recruiting
- Jinnah Hospital
-
Contact:
- Hafiza Mehjabeen, PhD
- Phone Number: 03026577666
- Email: hafiza.mehjabeen@riphah.edu.pk
-
Principal Investigator:
- Sameen Akhter, WHPT
-
Sub-Investigator:
- Hafiza Mehjabeen, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Third trimester Tinel's sign positive Phalen test positive Pregnant women with pain and numbness in wrist and fingers Women with tingling sensation in the wrist Nocturnal parasthesia in wrist and fingers
Exclusion Criteria:
Inflammatory joint disease Age above 35 years Wrist bone fractures Hand surgery Diabetes Gout Autoimmune disease Person with rheumatoid arthritis Any other abnormalities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nerve Glide Exercise with Ultra Sound
|
A brief demonstration will be given to perform the nerve glides exercises to both group.
The duration of exercise programmed is 15 minutes every 3 to 5 times per day for 4 weeks.
Group A will perform exercise with ultrasound
|
|
Active Comparator: Nerve Glide Exercise without Ultra Sound
|
Group B will perform exercise for 10 minutes every 3 to 5 times per day without ultrasound.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time Frame: 4 Week
|
To calculate score, add together the scores for all 11 questions in part 1, to give a total out of 55.(11)
|
4 Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale(VAS)
Time Frame: 4 weeks
|
To measure the pain response before and after treatment as no pain (0)severe pain (10)
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Severity Scale (SSS)
Time Frame: 4 weeks
|
Measure the severity of symptom.
Scores mild, moderat, severe & very severe
|
4 weeks
|
|
Functional Status Scale (FSS)
Time Frame: 4 weeks
|
Used to measure the functional disability of hand.
Scoring - No difficulty, mild difficulty, moderate difficulty & cant do at all
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hafiza Mahjabeen, PhD, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wolny T, Saulicz E, Linek P, Shacklock M, Mysliwiec A. Efficacy of Manual Therapy Including Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2017 May;40(4):263-272. doi: 10.1016/j.jmpt.2017.02.004. Epub 2017 Apr 8.
- Ashour AA, Yehia RM, ElMeligie MM, Hanafy AF. Effectiveness of high intensity laser therapy on pain, grip strength and median nerve conductivity in pregnant women with carpal tunnel syndrome: A randomized controlled trial. J Hand Ther. 2022 Jul 8:S0894-1130(22)00039-4. doi: 10.1016/j.jht.2022.03.005. Online ahead of print.
- Oliveira GAD, Bernardes JM, Santos ES, Dias A. Carpal tunnel syndrome during the third trimester of pregnancy: prevalence and risk factors. Arch Gynecol Obstet. 2019 Sep;300(3):623-631. doi: 10.1007/s00404-019-05233-6. Epub 2019 Jul 2.
- Keskin Y, Kilic G, Taspinar O, Posul SO, Halac G, Eren F, Erol E, Urkmez B, Aydin T. Effectiveness of home exercise in pregnant women with carpal tunnel syndrome: Randomized Control Trial. J Pak Med Assoc. 2020 Feb;70(2):202-207. doi: 10.5455/JPMA.1846.
- Bartkowiak Z, Eliks M, Zgorzalewicz-Stachowiak M, Romanowski L. The Effects of Nerve and Tendon Gliding Exercises Combined with Low-level Laser or Ultrasound Therapy in Carpal Tunnel Syndrome. Indian J Orthop. 2019 Mar-Apr;53(2):347-352. doi: 10.4103/ortho.IJOrtho_45_17.
- Nageswari C, Meena N, Devi TR. A Non Invasive Approach to Prevent Carpel Tunnel Syndrome of IT Women during Pregnancy
- VAIDYA S, NARIYA D. Effect of Neural Mobilisation Versus Nerve and Tendon Gliding Exercises in Carpal Tunnel Syndrome: A Randomised Clinical Trial. Journal of Clinical & Diagnostic Research. 2020;14(6)
- Sim SE, Gunasagaran J, Goh KJ, Ahmad TS. Short-term clinical outcome of orthosis alone vs combination of orthosis, nerve, and tendon gliding exercises and ultrasound therapy for treatment of carpal tunnel syndrome. J Hand Ther. 2019 Oct-Dec;32(4):411-416. doi: 10.1016/j.jht.2018.01.004. Epub 2018 Feb 13.
- Kadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. No abstract available.
- Price DD, Staud R, Robinson ME. How should we use the visual analogue scale (VAS) in rehabilitation outcomes? II: Visual analogue scales as ratio scales: an alternative to the view of Kersten et al. J Rehabil Med. 2012 Sep;44(9):800-1; discussion 803-4. doi: 10.2340/16501977-1031. No abstract available.
- Bougea A, Zambelis T, Voskou P, Katsika PZ, Tzavara C, Kokotis P, Karandreas N. Reliability and Validation of the Greek Version of the Boston Carpal Tunnel Questionnaire. Hand (N Y). 2018 Sep;13(5):593-599. doi: 10.1177/1558944717725379. Epub 2017 Aug 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2022
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
July 1, 2023
Study Registration Dates
First Submitted
May 4, 2023
First Submitted That Met QC Criteria
May 11, 2023
First Posted (Actual)
May 12, 2023
Study Record Updates
Last Update Posted (Actual)
May 12, 2023
Last Update Submitted That Met QC Criteria
May 11, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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