NCT05466162

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

April 9, 2022

Last Update Submit

July 17, 2022

Conditions

Keywords

peripheral neuropathycompression neuropathyentrapment neuropathysoft tissue massagemanual therapymassage therapyMedian neuropathy

Outcome Measures

Primary Outcomes (4)

  • 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.

    At baseline and after completion of study at after sixth week

  • 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.

    At baseline and after completion of study at after sixth week

  • 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.

    At baseline and after completion of study at sixth week

  • 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.

    At baseline and after completion of study at sixth week

Other Outcomes (2)

  • Change on Pain Anxiety Symptoms Scale-20

    At baseline and after completion of study at sixth week

  • Change on Center for Epidemiological Studies-Depression scale in scores

    At baseline and after completion of study at sixth week

Study Arms (2)

Soft tissue mobilization + joint and nerve Mobilization

EXPERIMENTAL

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.

Other: Soft tissue mobilizationOther: Joint and nerve mobilization

joint and nerve mobilizations

ACTIVE COMPARATOR

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

Other: Joint and nerve mobilization

Interventions

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

Also known as: Nerve mobilization( Slider technique), Joint mobilization
Soft tissue mobilization + joint and nerve Mobilization

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.

Soft tissue mobilization + joint and nerve Mobilizationjoint and nerve mobilizations

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (24)

  • 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.

    PMID: 28942118BACKGROUND
  • 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.

    PMID: 30930582BACKGROUND
  • 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.

    PMID: 27225142BACKGROUND
  • 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.

    PMID: 11418908BACKGROUND
  • 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.

    PMID: 1569433BACKGROUND
  • 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.

    PMID: 24632925BACKGROUND
  • 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.

    PMID: 28854251BACKGROUND
  • 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.

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

    PMID: 25630774BACKGROUND
  • 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.

    PMID: 29305236BACKGROUND
  • 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.

    PMID: 24728028BACKGROUND
  • 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.

    PMID: 26664397BACKGROUND
  • 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.

    PMID: 27513402BACKGROUND
  • 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.

    PMID: 29938668BACKGROUND
  • 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.

    PMID: 26962518BACKGROUND
  • Lewis KJ, Coppieters MW, Ross L, Hughes I, Vicenzino B, Schmid AB. Group education, night splinting and home exercises reduce conversion to surgery for carpal tunnel syndrome: a multicentre randomised trial. J Physiother. 2020 Apr;66(2):97-104. doi: 10.1016/j.jphys.2020.03.007. Epub 2020 Apr 11.

    PMID: 32291222BACKGROUND
  • Lindstrom-Hazel D, Kratt A, Bix L. Interrater reliability of students using hand and pinch dynamometers. Am J Occup Ther. 2009 Mar-Apr;63(2):193-7. doi: 10.5014/ajot.63.2.193.

    PMID: 19432057BACKGROUND
  • Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mosges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19.

    PMID: 28217433BACKGROUND
  • Madenci E, Altindag O, Koca I, Yilmaz M, Gur A. Reliability and efficacy of the new massage technique on the treatment in the patients with carpal tunnel syndrome. Rheumatol Int. 2012 Oct;32(10):3171-9. doi: 10.1007/s00296-011-2149-7. Epub 2011 Sep 28.

    PMID: 21953301BACKGROUND
  • Dinarvand V, Abdollahi I, Raeissadat SA, Mohseni Bandpei MA, Babaee M, Talimkhani A. The Effect of Scaphoid and Hamate Mobilization on Treatment of Patients with Carpal Tunnel Syndrome. Anesth Pain Med. 2017 Oct 23;7(5):e14621. doi: 10.5812/aapm.14621. eCollection 2017 Oct.

    PMID: 29696114BACKGROUND
  • Wolny T, Linek P. Is manual therapy based on neurodynamic techniques effective in the treatment of carpal tunnel syndrome? A randomized controlled trial. Clin Rehabil. 2019 Mar;33(3):408-417. doi: 10.1177/0269215518805213. Epub 2018 Oct 11.

    PMID: 30306805BACKGROUND
  • Wolny T, Linek P. Neurodynamic Techniques Versus "Sham" Therapy in the Treatment of Carpal Tunnel Syndrome: A Randomized Placebo-Controlled Trial. Arch Phys Med Rehabil. 2018 May;99(5):843-854. doi: 10.1016/j.apmr.2017.12.005. Epub 2018 Jan 4.

    PMID: 29307812BACKGROUND
  • De-la-Llave-Rincon AI, Ortega-Santiago R, Ambite-Quesada S, Gil-Crujera A, Puentedura EJ, Valenza MC, Fernandez-de-las-Penas C. Response of pain intensity to soft tissue mobilization and neurodynamic technique: a series of 18 patients with chronic carpal tunnel syndrome. J Manipulative Physiol Ther. 2012 Jul;35(6):420-7. doi: 10.1016/j.jmpt.2012.06.002. Epub 2012 Jul 31.

    PMID: 22858234BACKGROUND
  • Fernandez-de-Las-Penas C, Cleland J, Palacios-Cena M, Fuensalida-Novo S, Pareja JA, Alonso-Blanco C. The Effectiveness of Manual Therapy Versus Surgery on Self-reported Function, Cervical Range of Motion, and Pinch Grip Force in Carpal Tunnel Syndrome: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Mar;47(3):151-161. doi: 10.2519/jospt.2017.7090. Epub 2017 Feb 3.

    PMID: 28158963BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel SyndromePeripheral Nervous System DiseasesTomaculous neuropathyCharcot-Marie-Tooth DiseaseMedian Neuropathy

Condition Hierarchy (Ancestors)

MononeuropathiesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesHereditary Sensory and Motor NeuropathyNervous System MalformationsHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Hamna Syed, DPT

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Dr. Syed Imran Ahmed, MBBS,FCPS

    Sindh Institute of Physical Medicine and Rehabilitation

    STUDY DIRECTOR
  • Dr, Naila Naeem Shahbaz, MBBS,FCPS

    Dr. Ruth K.M. Pfau Civil Hospital, Karachi

    STUDY DIRECTOR
  • Aftab Ahmed Mirza Baig, DPT,MSAPT

    Sindh Institute of Physical Medicine and Rehabilitation

    STUDY DIRECTOR

Central Study Contacts

Hamna Syed, DPT

CONTACT

Dr.Syed Imran Ahmed, MBBS,FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The interventions assigned to individual participants will be kept hidden from the outcome assessors in the clinical trial.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hamna Syed

Study Record Dates

First Submitted

April 9, 2022

First Posted

July 20, 2022

Study Start

September 21, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations