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Carpal Tunnel SyndromeNCT05466162

Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome

A study testing Soft tissue mobilization and Joint and nerve mobilization in people with Carpal Tunnel Syndrome, run by Dow University of Health Sciences at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this experimental study is to determine the effect of soft tissue massage along with mobilization technique on intensity of pain by visual analog scale and functional status by using Jamar hand-held dynamometer, Pinch Gauge and Boston Scale for carpal tunnel syndrome questionnaire in Carpal tunnel… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Soft tissue mobilization and Joint and nerve mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
21 Sep 2021to Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Consultant Physiatrist will be diagnosed patients of carpal tunnel syndrome on electro diagnostic test i.e. Nerve Conduction Studies.
  • Mild and moderate severity of Carpal tunnel syndrome.
  • Age: 18-50 years
  • Both gender patients with unilateral involvement of the hand

Who cannot join

  • In electro diagnostic test, either motor or sensory deficit in the ulnar nerve and radial nerve.
  • Other Neurological problems ( cervical myelopathy, motor neuron disease like amyotrophic lateral sclerosis
  • Neoplasm around the affected arm
  • Presence of other musculoskeletal problems of upper quadrant (for example: rheumatoid arthritis or fibromyalgia, cervical radiculopathy)
  • Any recent history of trauma of upper extremity on affected side

Trial locations and contacts

1 site in 1 country.

Hamna Syed, DPT contact

+923043257150

hamnasyyd6@gmail.com

Dr.Syed Imran Ahmed, MBBS,FCPS contact

03002120661

syedimran77@gmail.com

Pakistan1 site, 1 recruiting
  • Sindh Institute of Physical Medicine and Rehabilitation

    Karachi, Sindh

    Hamna Syed, DPT, 03043257150, hamnasyyd6@gmail.com

    Dr.Syed Imran Ahmed, MBBS,FCPS, 03002120661, syedimran77@gmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Soft Tissue Massage Along With Mobilization Technique on Intensity of Symptoms and Functional Status of Carpal Tunnel Syndrome - A Randomized Controlled Trial

The objective of this experimental study is to determine the effect of soft tissue massage along with mobilization technique on intensity of pain by visual analog scale and functional status by using Jamar hand-held dynamometer, Pinch Gauge and Boston Scale for carpal tunnel syndrome questionnaire in Carpal tunnel syndrome patients. It is being conducted on patients with Carpal tunnel syndrome at Sindh Institute of Physical Medicine and Rehabilitation, Karachi and Neurological outpatient department of Dr. Ruth K. M. Pfau, Civil Hospital Karachi among Sixty participants with mild and moderate severity of Carpal Tunnel Syndrome will be randomly allocated in two groups after initial screening by a consultant physiatrist according to CTS-6 scale. Written informed consent will be taken from each participant. Group A will be treated with soft tissue massage (Medenci hand massage technique) along with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique while group B will be treated with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique only. Participant will be evaluated by visual analog pain scale, Boston scale of carpal tunnel syndrome, dynamometer and -pinch gauge, Center for Epidemiologic Studies Depression Scale and Pain Anxiety Symptoms Scale on day 1 and last treatment session.

Being tested
Soft tissue mobilization, Joint and nerve mobilization
Keywords
peripheral neuropathy, compression neuropathy, entrapment neuropathy, soft tissue massage, manual therapy, massage therapy, Median neuropathy
Medical subject headings
Carpal Tunnel Syndrome, Peripheral Nervous System Diseases, Tomaculous neuropathy, Charcot-Marie-Tooth Disease, Median Neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soft tissue mobilizationOther

    Also called Nerve mobilization( Slider technique), Joint mobilization

    Soft tissue massage therapy includes Madenci hand massage technique initiate with 30-second (sec) effleurage, followed by 60- sec friction, 30-sec petrissage, 30-sec shaking, and ends with 30-sec effleurage. It takes totally of 3 min Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

    Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

    . Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs

  • Joint and nerve mobilizationOther

    Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

    Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

    Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.

Study groups in NCT05466162
Study groupRoleWhat they receive
Soft tissue mobilization + joint and nerve MobilizationExperimentalSoft tissue massage therapy includes Madenci hand massage technique initiate with 30-second (sec) effleurage, followed by 60- sec friction, 30-sec petrissage, 30-sec shaking, and ends with 30-sec effleurage. It takes totally of 3 min Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step) Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step) . Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.
Receives: Other: Soft tissue mobilization; Other: Joint and nerve mobilization
joint and nerve mobilizationsActive comparatorInter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step) . Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs
Receives: Other: Joint and nerve mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain intensity on Visual Analog Scale in centimeter after sixth week

    Visual Analog Scale can be defined as a subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient in pain intensity measurement. The patients rate their pain intensity on 0 to 10 cm where 0 cm refers 'no pain' and 10 cm refers 'most excruciating pain'. Increase in number of cm suggests worst pain.

    Measured: At baseline and after completion of study at after sixth week

  2. Change in symptoms severity and functional status on scale of Boston Carpal Tunnel Questionnaire in scores

    It is a self-administered likert scale, containing two parts, namely the symptom severity scale and the functional status scale. It is used to assess the severity of symptoms and evaluate the difficulty in implementing the designated task. Symptom severity scale contains 11 items and the functional status scale contans 8 items. Higher the score in both scales indicating higher severity and more difficulty in performing the task.

    Scoring for Symptoms severity scale:

    Less than 11 or 11 = Asymptomatic, 12 to 22 = Mild, 23-33 = Moderate, 24-44 = Severe, 45-55 = Very Severe

    Scoring for Functional status scale:

    less than 8 or 8 = Asymptomatic, 9-16 = Mild, 17-24 = Moderate, 25-32 = Severe, 33-40 = Very Severe

    The total score of both scale is calculated as the mean of the scores for the total items of scale.

    Measured: At baseline and after completion of study at after sixth week

  3. Change in hand grip strength by using Jamar dynamometer

    Hand grip strength is quantify in kilogram by using Jamar dynamometer. Measurements was taken three times of each individuals and then calculated mean of these readings.

    Measured: At baseline and after completion of study at sixth week

  4. Change in pinch strength by using Pinch Gauge

    Pinch grip strength is measured in kilogram by using Pinch Gauge. Measurements was taken three times of each individuals and then calculated mean of these readings.

    Measured: At baseline and after completion of study at sixth week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study start21 Sep 2021
  3. Primary completionAug 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
It is a randomized controlled trial. Total 60 patients will be recruited, 30 in each group that includes There will be one interventional group and one control group. Treatment will be allocated by using a random number sheet generated by SPSS software version 21. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05466162
Sponsor's protocol ID
HamnaS
Status last verified
Jul 2022
First submitted
9 Apr 2022
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huisstede BM, Hoogvliet P, Franke TP, Randsdorp MS, Koes BW. Carpal Tunnel Syndrome: Effectiveness of Physical Therapy and Electrophysical Modalities. An Updated Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Aug;99(8):1623-1634.e23. doi: 10.1016/j.apmr.2017.08.482. Epub 2017 Sep 20.

    PubMed 28942118
  • Klokkari D, Mamais I. Effectiveness of surgical versus conservative treatment for carpal tunnel syndrome: A systematic review, meta-analysis and qualitative analysis. Hong Kong Physiother J. 2018 Dec;38(2):91-114. doi: 10.1142/S1013702518500087. Epub 2018 Jul 2.

    PubMed 30930582
  • Iftikhar S, Javed MA, Kasuri MN. Frequency of Metabolic Syndrome and Its Components in Patients with Carpal Tunnel Syndrome. J Coll Physicians Surg Pak. 2016 May;26(5):380-3.

    PubMed 27225142
  • Papanicolaou GD, McCabe SJ, Firrell J. The prevalence and characteristics of nerve compression symptoms in the general population. J Hand Surg Am. 2001 May;26(3):460-6. doi: 10.1053/jhsu.2001.24972.

    PubMed 11418908
  • de Krom MC, Knipschild PG, Kester AD, Thijs CT, Boekkooi PF, Spaans F. Carpal tunnel syndrome: prevalence in the general population. J Clin Epidemiol. 1992 Apr;45(4):373-6. doi: 10.1016/0895-4356(92)90038-o.

    PubMed 1569433
  • Nataraj R, Evans PJ, Seitz WH Jr, Li ZM. Effects of carpal tunnel syndrome on reach-to-pinch performance. PLoS One. 2014 Mar 14;9(3):e92063. doi: 10.1371/journal.pone.0092063. eCollection 2014.

    PubMed 24632925
  • Soon B, Vicenzino B, Schmid AB, Coppieters MW. Facilitatory and inhibitory pain mechanisms are altered in patients with carpal tunnel syndrome. PLoS One. 2017 Aug 30;12(8):e0183252. doi: 10.1371/journal.pone.0183252. eCollection 2017.

    PubMed 28854251
  • Newington L, Harris EC, Walker-Bone K. Carpal tunnel syndrome and work. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):440-53. doi: 10.1016/j.berh.2015.04.026. Epub 2015 May 27.

    PubMed 26612240
  • Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9.

    PubMed 25630774
  • Shin YH, Yoon JO, Kim YK, Kim JK. Psychological Status Is Associated With Symptom Severity in Patients With Carpal Tunnel Syndrome. J Hand Surg Am. 2018 May;43(5):484.e1-484.e8. doi: 10.1016/j.jhsa.2017.10.031. Epub 2018 Jan 3.

    PubMed 29305236
  • Koca I, Boyaci A, Tutoglu A, Ucar M, Kocaturk O. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatol Int. 2014 Dec;34(12):1639-45. doi: 10.1007/s00296-014-3005-3. Epub 2014 Apr 12.

    PubMed 24728028
  • Eftekharsadat B, Babaei-Ghazani A, Habibzadeh A. The Efficacy of 100 and 300 mg Gabapentin in the Treatment of Carpal Tunnel Syndrome. Iran J Pharm Res. 2015 Fall;14(4):1275-80.

    PubMed 26664397
  • Geler Kulcu D, Bursali C, Aktas I, Bozkurt Alp S, Unlu Ozkan F, Akpinar P. Kinesiotaping as an alternative treatment method for carpal tunnel syndrome. Turk J Med Sci. 2016 Jun 23;46(4):1042-9. doi: 10.3906/sag-1503-4.

    PubMed 27513402
  • Chung VC, Wong SY, Kung K, Zee CY, Leung WN, Chong KC, Wong M, Wong C, Griffiths SM. Electroacupuncture and wrist splinting for carpal tunnel syndrome: a randomised trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):28-31. No abstract available.

    PubMed 29938668
  • Khosrawi S, Emadi M, Mahmoodian AE. Effectiveness of splinting and splinting plus local steroid injection in severe carpal tunnel syndrome: A Randomized control clinical trial. Adv Biomed Res. 2016 Feb 8;5:16. doi: 10.4103/2277-9175.175902. eCollection 2016.

    PubMed 26962518

Questions about this trial

What is this clinical trial studying?

A study testing Soft tissue mobilization and Joint and nerve mobilization in people with Carpal Tunnel Syndrome, run by Dow University of Health Sciences at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hamna Syed, DPT (+923043257150, hamnasyyd6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain intensity on Visual Analog Scale in centimeter after sixth week (time frame: At baseline and after completion of study at after sixth week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05466162, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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