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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05855993
Other study ID # REC/RCR & AHS/23/0520
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 6, 2022
Est. completion date July 2023

Study information

Verified date May 2023
Source Riphah International University
Contact Imran Amjad, PhD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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
Nerve Glide Exercise without Ultra Sound
Group B will perform exercise for 10 minutes every 3 to 5 times per day without ultrasound.

Locations

Country Name City State
Pakistan Jinnah Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Nageswari C, Meena N, Devi TR. A Non Invasive Approach to Prevent Carpel Tunnel Syndrome of IT Women during Pregnancy

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. — View 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. — View 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. — View 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)

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Symptom Severity Scale (SSS) Measure the severity of symptom. Scores mild, moderat, severe & very severe 4 weeks
Other Functional Status Scale (FSS) Used to measure the functional disability of hand. Scoring - No difficulty, mild difficulty, moderate difficulty & cant do at all 4 weeks
Primary 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) 4 Week
Secondary Visual Analog Scale(VAS) To measure the pain response before and after treatment as no pain (0)severe pain (10) 4 weeks
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