NCT06509633

Brief Summary

The aim of this study is to check the effects of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

July 15, 2024

Last Update Submit

July 18, 2024

Conditions

Wrist InjuriesCarpal Tunnel Syndrome

Keywords

Carpal tunnel syndromeCompressionPain neuroscience educationMedian nerve

Outcome Measures

Primary Outcomes (1)

  • Numeric pain rate scale (NPRS)

    Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain.

    4th week

Secondary Outcomes (1)

  • Pain Catastrophizing Scale (PCS)

    4th week

Other Outcomes (2)

  • Boston Carpal Tunnel Questionnaire (BCTQ)

    4th week

  • Goniometer

    4th week

Study Arms (2)

Pain Neuroscience education and Standard Rehabilitation regime

EXPERIMENTAL

Patients will get standard treatment of CTS, which is nerve gliding, stretchings of forearm and wrist muscles and wrist mobilization along with pain neuroscience education.

Other: Pain Neuroscience education and standard rehabilitation regime

standard Rehabilitation regime

ACTIVE COMPARATOR

Patient will get only nerve gliding and wrist forearm muscle stretching exercises.

Other: standard Rehabilitation regime

Interventions

Pain Neuroscience education and standard rehabilitation regimeOTHER

Median nerve gliding exercises, wrist and forearm muscle stretches, wrist mobilizations and finger joint mobilizations

Also known as: Standard Rehabilitation regime
Pain Neuroscience education and Standard Rehabilitation regime
standard Rehabilitation regimeOTHER

standard Rehabilitation regime

standard Rehabilitation regime

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCarpal Tunnel syndrome is prevalent in female housewives and computer users.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 20\_40 years old.
  • Medical diagnosis of moderate to severe CTS.
  • Symptoms of CTS since 1month
  • Unilateral or bilateral symptoms
  • Availability and access to the hospital.

You may not qualify if:

  • Inability to understand instructions, neurological conditions of the central nervous system (e.g. stroke, spinal cord injury)
  • Patients on treatment with alternative therapies
  • Previous participation in a research program
  • Previous surgery on the affected upper limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Absaar medical center

Lahore, Punjab Province, 56300, Pakistan

RECRUITING

Related Publications (11)

  • Werner RA, Andary M. Electrodiagnostic evaluation of carpal tunnel syndrome. Muscle Nerve. 2011 Oct;44(4):597-607. doi: 10.1002/mus.22208.

    PMID: 21922474BACKGROUND

  • Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.

    PMID: 32313774BACKGROUND

  • Nunez-Cortes R, Espinoza-Ordonez C, Pommer PP, Horment-Lara G, Perez-Alenda S, Cruz-Montecinos C. A single preoperative pain neuroscience education: Is it an effective strategy for patients with carpal tunnel syndrome? Med Hypotheses. 2019 May;126:46-50. doi: 10.1016/j.mehy.2019.03.013. Epub 2019 Mar 22.

    PMID: 31010499BACKGROUND

  • Nunez-Cortes R, Cruz-Montecinos C, Torreblanca-Vargas S, Tapia C, Gutierrez-Jimenez M, Torres-Gangas P, Calatayud J, Perez-Alenda S. Effectiveness of adding pain neuroscience education to telerehabilitation in patients with carpal tunnel syndrome: A randomized controlled trial. Musculoskelet Sci Pract. 2023 Oct;67:102835. doi: 10.1016/j.msksp.2023.102835. Epub 2023 Jul 28.

    PMID: 37572618BACKGROUND

  • Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.

    PMID: 27842937BACKGROUND

  • Bulow K, Lindberg K, Vaegter HB, Juhl CB. Effectiveness of Pain Neurophysiology Education on Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Pain Med. 2021 Apr 20;22(4):891-904. doi: 10.1093/pm/pnaa484.

    PMID: 33764394BACKGROUND

  • Louw A, Puentedura EJ, Zimney K, Schmidt S. Know Pain, Know Gain? A Perspective on Pain Neuroscience Education in Physical Therapy. J Orthop Sports Phys Ther. 2016 Mar;46(3):131-4. doi: 10.2519/jospt.2016.0602.

    PMID: 26928735BACKGROUND

  • Ziegler AM, Minkalis AL, Langdon ER, Vining R. Learning the neurobiology of pain: A scoping review of pain education from an instructional design perspective. Patient Educ Couns. 2022 Jun;105(6):1379-1401. doi: 10.1016/j.pec.2021.09.021. Epub 2021 Sep 14.

    PMID: 34579995BACKGROUND

  • Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Cleland JA, Cook C, de-la-Llave-Rincon AI, Valera-Calero JA, Plaza-Manzano G. Minimal Clinically Important Differences in Hand Pain Intensity (Numerical Pain Rate Scale) and Related-Function (Boston Carpal Tunnel Questionnaire) in Women With Carpal Tunnel Syndrome. Arch Phys Med Rehabil. 2024 Jan;105(1):67-74. doi: 10.1016/j.apmr.2023.07.018. Epub 2023 Aug 13.

    PMID: 37582474BACKGROUND

  • Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychological assessment. 1995;7(4):524.

    BACKGROUND

  • Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.

    PMID: 8245050BACKGROUND

MeSH Terms

Conditions

Wrist InjuriesCarpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesMedian NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and Strains

Study Officials

  • Saba khan

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad

CONTACT

03324390125Imran.amjad@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 19, 2024

Study Start

February 1, 2024

Primary Completion

October 10, 2024

Study Completion

November 10, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)