Osteoarthritis, KneeNCT04995250
Effects of Corrective Exercise Training for Improving Neuropathic Pain and Function in Knee Osteoarthritis
A study testing corrective exercise training for knee in people with Osteoarthritis, Knee, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- corrective exercise training for knee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2020to 30 Dec 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Crepitus on active motion
- Bony tenderness
- Bony enlargement
- No palpable warmth of synovium
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- corrective exercise training for knee
- Keywords
- Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corrective exercise training for kneeOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Corrective exercise training for knee Osteoarthritis | Experimental | Not described Receives: Other: corrective exercise training for knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Osteoarthritis Index
0-100, 0 means no disability 100 means maximum disability
Measured: 6 months
Numeric pain rating scale
0-10,no pain and the worse pain, on an 11 point scale
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Apr 2020
- Primary completion30 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Shabbir, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995250
- Sponsor's protocol ID
- REC/Lhr/1065
- Status last verified
- Aug 2021
- First submitted
- 26 Mar 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29901006Nelson 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.
PubMed 24387819Knoop 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.
PubMed 21251988Takacs 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.
PubMed 23696951Beckwee 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.
PubMed 23026409Sazo-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.
PubMed 28744054
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Corrective Exercise Training for Improving Neuropathic Pain and Function in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04995250
- Acronym / sponsor ID
- REC/Lhr/1065
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corrective exercise training for knee Osteoarthritis | Experimental | Other: corrective exercise training for knee |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- ACR Criteria for osteoarthritis
- Neuropathic pain
- Age over 65
- DN4 cut off value is 4/10
- Less than 30 minutes of morning stiffness
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corrective exercise training for kneeAll 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). | Other | Corrective exercise training for knee Osteoarthritis |
Primary outcome
Western Ontario and McMaster Osteoarthritis Index
Time frame: 6 months
0-100, 0 means no disability 100 means maximum disability
Numeric pain rating scale
Time frame: 6 months
0-10,no pain and the worse pain, on an 11 point scale
Douleur Neuropathique 4 Questionnaire
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Background: PubMed 29901006Polat 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.
- Background: PubMed 24387819Nelson 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.
- Background: PubMed 21251988Knoop 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.
- Background: PubMed 23696951Takacs 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.
- Background: PubMed 23026409Beckwee 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.
- Background: PubMed 28744054Sazo-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.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Shabbir, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corrective exercise training for knee in people with Osteoarthritis, Knee, run by Riphah International University 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Osteoarthritis Index (time frame: 6 months). The study lists 3 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 NCT04995250, which also lists 6 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 2 Sep 2021.