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Neural Glides With and Without Therapeutic Ultra Sound on in Pregnant Computer Workers With Carpal Tunnel Syndrome

Primary Purpose

Pregnancy Related

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Nerve Glide Exercise with Ultra Sound
Nerve Glide Exercise without Ultra Sound
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related focused on measuring CTS, Functional Status Scale, Non Invasive Methods

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Jinnah HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nerve Glide Exercise with Ultra Sound

Nerve Glide Exercise without Ultra Sound

Arm Description

Outcomes

Primary Outcome Measures

Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
To calculate score, add together the scores for all 11 questions in part 1, to give a total out of 55.(11)

Secondary Outcome Measures

Visual Analog Scale(VAS)
To measure the pain response before and after treatment as no pain (0)severe pain (10)

Full Information

First Posted
May 4, 2023
Last Updated
May 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05855993
Brief Title
Neural Glides With and Without Therapeutic Ultra Sound on in Pregnant Computer Workers With Carpal Tunnel Syndrome
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
To study the effects of Neural Glides with and without using therapeutic ultrasound and functional status in pregnant computer workers with CTS
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related
Keywords
CTS, Functional Status Scale, Non Invasive Methods

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nerve Glide Exercise with Ultra Sound
Arm Type
Experimental
Arm Title
Nerve Glide Exercise without Ultra Sound
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Nerve Glide Exercise with Ultra Sound
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Nerve Glide Exercise without Ultra Sound
Intervention Description
Group B will perform exercise for 10 minutes every 3 to 5 times per day without ultrasound.
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Description
To calculate score, add together the scores for all 11 questions in part 1, to give a total out of 55.(11)
Time Frame
4 Week
Secondary Outcome Measure Information:
Title
Visual Analog Scale(VAS)
Description
To measure the pain response before and after treatment as no pain (0)severe pain (10)
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Symptom Severity Scale (SSS)
Description
Measure the severity of symptom. Scores mild, moderat, severe & very severe
Time Frame
4 weeks
Title
Functional Status Scale (FSS)
Description
Used to measure the functional disability of hand. Scoring - No difficulty, mild difficulty, moderate difficulty & cant do at all
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Mahjabeen, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, PhD
Phone
03026577666
Email
hafiza.mehjabeen@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sameen Akhter, WHPT
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35817691
Citation
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.
Results Reference
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PubMed Identifier
31267198
Citation
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.
Results Reference
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PubMed Identifier
32063607
Citation
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.
Results Reference
background
PubMed Identifier
30967707
Citation
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.
Results Reference
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Citation
Nageswari C, Meena N, Devi TR. A Non Invasive Approach to Prevent Carpel Tunnel Syndrome of IT Women during Pregnancy
Results Reference
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Citation
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)
Results Reference
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PubMed Identifier
29426574
Citation
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.
Results Reference
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PubMed Identifier
28395984
Citation
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.
Results Reference
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PubMed Identifier
20532100
Citation
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.
Results Reference
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PubMed Identifier
22915047
Citation
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.
Results Reference
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PubMed Identifier
28825339
Citation
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.
Results Reference
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Neural Glides With and Without Therapeutic Ultra Sound on in Pregnant Computer Workers With Carpal Tunnel Syndrome

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