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Effects of Corrective Exercise Training for Improving Neuropathic Pain and Function in Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

corrective exercise training for knee

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee osteoarthritis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Riphah Rehabilitation Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Corrective exercise training for knee Osteoarthritis

Arm Description

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Osteoarthritis Index

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

Numeric pain rating scale

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04995250

First Posted

March 26, 2021

Last Updated

August 27, 2021

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT04995250

Brief Title

Effects of Corrective Exercise Training for Improving Neuropathic Pain and Function in Knee Osteoarthritis

Official Title

Effects of Corrective Exercise Training for Improving Neuropathic Pain and Function in Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study was a Quasi experimental study. It was conducted at Horizon Hospital Johar Town Lahore. The study was completed in Six months. Consecutive sampling technique was used to collect the data. The sample size of 16 patients was taken in this study to find out the effects of corrective exercises training for improving neuropathic pain and function in patients with knee osteoarthritis. For descriptive analysis we used frequency, percentages and charts. For quantitative measure. Repeated Measured ANOVA was used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Knee osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Corrective exercise training for knee Osteoarthritis

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

corrective exercise training for knee

Intervention Description

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).

Primary Outcome Measure Information:

Title

Western Ontario and McMaster Osteoarthritis Index

Description

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

Time Frame

6 months

Title

Numeric pain rating scale

Description

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

Time Frame

6 months

Title

Douleur Neuropathique 4 Questionnaire

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maryam Shabbir, MS

Organizational Affiliation

Riphah International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Riphah Rehabilitation Center

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29901006

Citation

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.

Results Reference

background

PubMed Identifier

24387819

Citation

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.

Results Reference

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PubMed Identifier

21251988

Citation

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.

Results Reference

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PubMed Identifier

23696951

Citation

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.

Results Reference

background

PubMed Identifier

23026409

Citation

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.

Results Reference

background

PubMed Identifier

28744054

Citation

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.

Results Reference

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Effects of Corrective Exercise Training for Improving Neuropathic Pain and Function in Knee Osteoarthritis

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