NCT04995250

Brief Summary

Patients with neuropathic pain had longer duration of symptoms increased severity of pain, functional limitation and disability as compare to the patient with general knee osteoarthritis. Objective: To find out the effects of corrective exercise training for improving neuropathic pain and function in knee OA patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

March 26, 2021

Last Update Submit

August 27, 2021

Conditions

Keywords

Knee osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Western Ontario and McMaster Osteoarthritis Index

    0-100, 0 means no disability 100 means maximum disability

    6 months

  • Numeric pain rating scale

    0-10,no pain and the worse pain, on an 11 point scale

    6 months

  • Douleur Neuropathique 4 Questionnaire

    The total score is calculated as the sum of 10 items and the cut off value for the diagnosis of neuropathic pain is a total score of 4/10

    6 months

Study Arms (1)

Corrective exercise training for knee Osteoarthritis

EXPERIMENTAL
Other: corrective exercise training for knee

Interventions

All patients received 12 weeks (3 days per week) physiotherapy sessions with hot pack, TENS and Ultrasound session for 10 mints and knee isometric, quad strengthening, adductor and abductor strengthening, calf stretch, hamstring stretch, Maitland mobilization, Unconventional Corrective knee exercise protocol treatment: standing on one extremity, up and down on bosu exercise, walking to lateral direction, walking to anterio-posterior direction, walking to anterio-posterior and lateral for 20 mints. Data were collected at baseline, at week 4 and at post treatment (week 12).

Corrective exercise training for knee Osteoarthritis

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ACR Criteria for osteoarthritis
  • Neuropathic pain
  • Age over 65
  • DN4 cut off value is 4/10
  • Less than 30 minutes of morning stiffness
  • Grade I and II
  • Crepitus on active motion
  • Bony tenderness
  • Bony enlargement
  • No palpable warmth of synovium

You may not qualify if:

  • Knee complain that require urgent medical attention (fracture and infection)
  • Diabetes mellitus
  • Patients with malignancies
  • Neurological disorders
  • Systematic musculoskeletal diseases (Parkinson's, rheumatoid arthritis etc)
  • Incapability of understanding implication of participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • Polat CS, Dogan A, Sezgin Ozcan D, Koseoglu BF, Kocer Akselim S. Is There a Possible Neuropathic Pain Component in Knee Osteoarthritis? Arch Rheumatol. 2017 Apr 24;32(4):333-338. doi: 10.5606/ArchRheumatol.2017.6006. eCollection 2017 Dec.

    PMID: 29901006BACKGROUND
  • Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.

    PMID: 24387819BACKGROUND
  • Knoop J, Steultjens MP, van der Leeden M, van der Esch M, Thorstensson CA, Roorda LD, Lems WF, Dekker J. Proprioception in knee osteoarthritis: a narrative review. Osteoarthritis Cartilage. 2011 Apr;19(4):381-8. doi: 10.1016/j.joca.2011.01.003. Epub 2011 Jan 18.

    PMID: 21251988BACKGROUND
  • Takacs J, Carpenter MG, Garland SJ, Hunt MA. The role of neuromuscular changes in aging and knee osteoarthritis on dynamic postural control. Aging Dis. 2013 Jan 15;4(2):84-99. Print 2013 Apr.

    PMID: 23696951BACKGROUND
  • Beckwee D, Vaes P, Cnudde M, Swinnen E, Bautmans I. Osteoarthritis of the knee: why does exercise work? A qualitative study of the literature. Ageing Res Rev. 2013 Jan;12(1):226-36. doi: 10.1016/j.arr.2012.09.005. Epub 2012 Sep 28.

    PMID: 23026409BACKGROUND
  • Sazo-Rodriguez S, Mendez-Rebolledo G, Guzman-Munoz E, Rubio-Palma P. The effects of progressive neuromuscular training on postural balance and functionality in elderly patients with knee osteoarthritis: a pilot study. J Phys Ther Sci. 2017 Jul;29(7):1229-1235. doi: 10.1589/jpts.29.1229. Epub 2017 Jul 15.

    PMID: 28744054BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Maryam Shabbir, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

August 6, 2021

Study Start

April 1, 2020

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations