Knee OsteoarthritisDiKAPNCT04331990
The Distraction of Knee Joint to Alleviate osteoArthritic Pain (DiKAP) Trial
A study testing Standard Physcial Therapy, Intermittent Mechanical Traction and Continuous Mechanical Traction in people with Knee Osteoarthritis, run by Prince Sultan Military College of Health Sciences.
Trial summary
This is a randomized controlled trial examining the short- and long-term effects of mechanical nonsurgical knee joint traction on knee pain, function, and quality of life. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Standard Physcial Therapy, Intermittent Mechanical Traction and Continuous Mechanical Traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥40 years of age;
- having knee pain;
- having at least three of the following additional symptoms: a-morning stiffness ≤ 30 minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable warmth;
- willing to provide informed consent
Who cannot join
- rheumatoid arthritis;
- serious pathological conditions (inflammatory arthritis and malignancy); total or partial arthroplasty of the affected knee joint, or on waiting list for joint replacement surgery;
- recent surgical procedure of the lower extremities in the previous 6 months;
- uncontrolled hypertension and unstable cardiovascular problems that could subject the participant to increased risk with exercise and physical exertion;
- physical incapability to safely perform exercises, walking or stationary cycling, as in: debilitating visual defects, neurological problems, exaggerated low back pain, advanced osteoporosis, and inability to walk 10 meters without an assistive device;
- use of prescribed analgesics, corticosteroid or analgesic injection intervention for knee pain within the previous 30 days;
- lack of clear comprehension of study procedures or inability to comply with instructions;
- stated inability to attend or complete the proposed course of intervention and follow-up schedule.
Trial locations and contacts
No sites are listed yet.
Ahmed Farrag contact
About this study
Official title: Efficacy of Adding Mechanical Nonsurgical Knee Traction to Standard Physical Therapy Rehabilitation of Knee Osteoarthritis: a Randomized Controlled Trial
This is a randomized controlled trial examining the short- and long-term effects of mechanical nonsurgical knee joint traction on knee pain, function, and quality of life.
Read the detailed description
Knee OA symptoms are known to be impacted by increased joint loading and reduced joint space width between the articulating bones.
Objectives:
- Primary objective: Investigate the short- and long-term efficacy of adding nonsurgical knee joint distraction to standard multimodal physical therapy treatment on pain, joint function and quality of life in patients with knee OA compared with standard physical therapy treatment alone.
- Secondary objective: examine whether the efficacy of mechanical traction would differ based on the mode of application (continuous vs. intermittent traction).
Design and Subjects: A prospective, active control, three-parallel-group, investigator-blinded, randomized controlled trial. 198 subjects will be recruited and randomly assigned to one of three study groups at a 1:1:1 allocation ratio (66 participants per group): a) Standard care only, b) continuous mechanical traction plus standard care, and c) intermittent mechanical traction plus standard care.
Intervention: Participants in the standard care only group will receive 16 treatment sessions (2sessions/week) over 8 weeks, followed by 4 booster sessions (1session/2months) during the one-year period of the trial. Mechanical traction groups will receive standard care in addition to 20-minute knee traction (continuous or intermittent) using an external weight applying knee traction force.
Outcome measures: The primary outcomes are physical function and pain assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include the Numeric Pain Rating Scale, quality of life, Timed Up and Go, 40m fast-paced walk, and 30s chair stand tests, patient's self-perceived efficacy of treatment and patient's global assessment.
Data Analysis: Data will be analyzed using the intension-to-treat (ITT) analysis with multiple imputations. The per-protocol analysis will be carried out and reported if its findings are different from those of the primary ITT analysis. The primary analysis of the primary outcomes at two- and six-month follow-up time points will be carried out using analysis of covariance (ANCOVA) test with adjustment for a set of pre-specified baseline covariates. Secondary analysis using ANCOVA test for the primary outcomes at the 12-month time point, and secondary outcomes at all follow-up time points will also be carried out.
- Conditions
- Knee Osteoarthritis
- Being tested
- Standard Physcial Therapy, Intermittent Mechanical Traction, Continuous Mechanical Traction
- Keywords
- Knee, Osteoarthritis, Pain, Joint distraction
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physcial TherapyOther
Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), muscle strengthening and stretching, and neuromuscular control exercises. Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
Intermittent Mechanical TractionOther
In addition to the standard treatment, patients in this group will receive intermittent knee joint decompression for 20 minutes. Patients will be lying supine with the knee semiflexed to 30° and supported by a wedge under the knee. A customized leg cuff will be placed around the lower leg and two ropes will be extending horizontally from the cuff to the vertical traction weight using a pulley system to transfer the traction force to the tibiofemoral articulation. The magnitude of the traction force will be between 10-15% of the patient's body weight. The traction force will be applied for 10 application cycles; each cycle comprised of 2 minutes traction followed by 30 seconds relief. This will sum up to 20 minutes of actual joint traction duration. The traction force application and relief time will be controlled manually by the treating therapist. Knee joint traction procedures will be applied at the end of the physical therapy session.
Continuous Mechanical TractionOther
Patients assigned to this group will receive the same treatment protocol as those in the Intermittent Mechanical Traction group. However, the knee traction force will be applied continuously for 20 minutes without intermittent force relief periods.
| Study group | Role | What they receive |
|---|---|---|
| Standard Physical Therapy | Active comparator | Control group for the study. Intervention in the form of warm-up and strengthening, stretching and neuromuscular control exercises. Receives: Other: Standard Physcial Therapy |
| Intermittent Mechanical Traction | Experimental | Standard care in addition to intermittent mechanical distraction of the knee joint. Receives: Other: Intermittent Mechanical Traction |
| Continuous Mechanical Traction | Experimental | Standard care in addition to continuous mechanical distraction of the knee joint Receives: Other: Continuous Mechanical Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
A 5-point Likert scale comprised of 42 questions across 5 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Baseline, 2, 6 and 12 months follow-up
Change in physical function score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
A 5-point Likert scale comprised of 42 questions across 5 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Baseline, 2, 6 and 12 months follow-up
Secondary outcomes (8)
Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)
A horizontal 11-point scale (0-10), with 0 indicating no pain and 10 indicating the worst pain ever.
Measured: Baseline, 2, 6 and 12 months follow-up
Change in Patient's Global Assessment
A single question using a 7-point Likert scale (1 indicates much worse, and 7 indicates much better).
Measured: 2, 6, 12 months follow-up
Change in Health-related Quality of Life score using the Arabic version of the Short Form 36 (SF-36) scale
A 36-item scale with a score ranging from 0 (worst health status) to 100 (best health status).
Measured: Baseline, 2, 6 and 12 months follow-up
Change in the time taken to complete the Timed Up and Go (TUG)
Time (seconds) taken to rise from a chair, walk 3m, turn, walk back to the chair, then sit down
Measured: Baseline, 2, 6 and 12 months follow-up
Change in the wakling speed for the 40m fast-paced walk test
The walking speed (m/s) will be recorded to walk quickly and safely over a 10m walkway for a total of 40m (4 x 10m).
Measured: Baseline, 2, 6 and 12 months follow-up
Change in number of repetitions during the 30s chair stand test
The maximum number of chair stand repetitions possible in a 30 second period is counted and recorded.
Measured: Baseline, 2, 6 and 12 months follow-up
change in the Patient's Self-perceived Efficacy of treatment
A single question inquiring about the patient's perception regarding the effectiveness of physical therapy intervention to improve the OA symptoms. A 5-point Likert scale (1 indicates not effective, and 5 indicates greatly effective).
Measured: 2, 6 and 12 months follow-up
Change in other subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS (Symptoms, Sport and Recreation Function, and knee-related Quality of Life).
A 5-point Likert scale comprised of 42 questions across 5 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Baseline, 2, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study startSep 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince Sultan Military College of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Farrag, Prince Sultan Military College of Health Sciences
- Investigators
- Ahmed Farrag, PhD, Principal investigator, Prince Sultan Military College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331990
- Sponsor's protocol ID
- PT-2020-02
- Acronym
- DiKAP
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Mechanical Nonsurgical Knee Traction to Standard Physical Therapy Rehabilitation of Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04331990
- Acronym / sponsor ID
- DiKAP / PT-2020-02
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Pain, Joint distraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Prince Sultan Military College of Health SciencesUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Apr 2020 (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.
This is a randomized controlled trial examining the short- and long-term effects of mechanical nonsurgical knee joint traction on knee pain, function, and quality of life.
Detailed description
Knee OA symptoms are known to be impacted by increased joint loading and reduced joint space width between the articulating bones.
Objectives:
- Primary objective: Investigate the short- and long-term efficacy of adding nonsurgical knee joint distraction to standard multimodal physical therapy treatment on pain, joint function and quality of life in patients with knee OA compared with standard physical therapy treatment alone.
- Secondary objective: examine whether the efficacy of mechanical traction would differ based on the mode of application (continuous vs. intermittent traction).
Design and Subjects: A prospective, active control, three-parallel-group, investigator-blinded, randomized controlled trial. 198 subjects will be recruited and randomly assigned to one of three study groups at a 1:1:1 allocation ratio (66 participants per group): a) Standard care only, b) continuous mechanical traction plus standard care, and c) intermittent mechanical traction plus standard care.
Intervention: Participants in the standard care only group will receive 16 treatment sessions (2sessions/week) over 8 weeks, followed by 4 booster sessions (1session/2months) during the one-year period of the trial. Mechanical traction groups will receive standard care in addition to 20-minute knee traction (continuous or intermittent) using an external weight applying knee traction force.
Outcome measures: The primary outcomes are physical function and pain assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include the Numeric Pain Rating Scale, quality of life, Timed Up and Go, 40m fast-paced walk, and 30s chair stand tests, patient's self-perceived efficacy of treatment and patient's global assessment.
Data Analysis: Data will be analyzed using the intension-to-treat (ITT) analysis with multiple imputations. The per-protocol analysis will be carried out and reported if its findings are different from those of the primary ITT analysis. The primary analysis of the primary outcomes at two- and six-month follow-up time points will be carried out using analysis of covariance (ANCOVA) test with adjustment for a set of pre-specified baseline covariates. Secondary analysis using ANCOVA test for the primary outcomes at the 12-month time point, and secondary outcomes at all follow-up time points will also be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Physical Therapy | Active comparator | Other: Standard Physcial TherapyControl group for the study. Intervention in the form of warm-up and strengthening, stretching and neuromuscular control exercises. |
| Intermittent Mechanical Traction | Experimental | Other: Intermittent Mechanical TractionStandard care in addition to intermittent mechanical distraction of the knee joint. |
| Continuous Mechanical Traction | Experimental | Other: Continuous Mechanical TractionStandard care in addition to continuous mechanical distraction of the knee joint |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥40 years of age;
- having knee pain;
- having at least three of the following additional symptoms: a-morning stiffness ≤ 30 minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable warmth;
- willing to provide informed consent
Key exclusion criteria (8 listed)
- rheumatoid arthritis;
- serious pathological conditions (inflammatory arthritis and malignancy); total or partial arthroplasty of the affected knee joint, or on waiting list for joint replacement surgery;
- recent surgical procedure of the lower extremities in the previous 6 months;
- uncontrolled hypertension and unstable cardiovascular problems that could subject the participant to increased risk with exercise and physical exertion;
- physical incapability to safely perform exercises, walking or stationary cycling, as in: debilitating visual defects, neurological problems, exaggerated low back pain, advanced osteoporosis, and inability to walk 10 meters without an assistive device;
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 |
|---|---|---|
| Standard Physcial TherapyPatients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), muscle strengthening and stretching, and neuromuscular control exercises. Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises. | Other | Standard Physical Therapy |
| Intermittent Mechanical TractionIn addition to the standard treatment, patients in this group will receive intermittent knee joint decompression for 20 minutes. Patients will be lying supine with the knee semiflexed to 30° and supported by a wedge under the knee. A customized leg cuff will be placed around the lower leg and two ropes will be extending horizontally from the cuff to the vertical traction weight using a pulley system to transfer the traction force to the tibiofemoral articulation. The magnitude of the traction force will be between 10-15% of the patient's body weight. The traction force will be applied for 10 application cycles; each cycle comprised of 2 minutes traction followed by 30 seconds relief. This will sum up to 20 minutes of actual joint traction duration. The traction force application and relief time will be controlled manually by the treating therapist. Knee joint traction procedures will be applied at the end of the physical therapy session. | Other | Intermittent Mechanical Traction |
| Continuous Mechanical TractionPatients assigned to this group will receive the same treatment protocol as those in the Intermittent Mechanical Traction group. However, the knee traction force will be applied continuously for 20 minutes without intermittent force relief periods. | Other | Continuous Mechanical Traction |
Primary outcome
Change in pain score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 2, 6 and 12 months follow-up
A 5-point Likert scale comprised of 42 questions across 5 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Change in physical function score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 2, 6 and 12 months follow-up
A 5-point Likert scale comprised of 42 questions across 5 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
8 secondary outcomes
Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)
Time frame: Baseline, 2, 6 and 12 months follow-up
Change in Patient's Global Assessment
Time frame: 2, 6, 12 months follow-up
Change in Health-related Quality of Life score using the Arabic version of the Short Form 36 (SF-36) scale
Time frame: Baseline, 2, 6 and 12 months follow-up
Change in the time taken to complete the Timed Up and Go (TUG)
Time frame: Baseline, 2, 6 and 12 months follow-up
Change in the wakling speed for the 40m fast-paced walk test
Time frame: Baseline, 2, 6 and 12 months follow-up
Change in number of repetitions during the 30s chair stand test
Time frame: Baseline, 2, 6 and 12 months follow-up
change in the Patient's Self-perceived Efficacy of treatment
Time frame: 2, 6 and 12 months follow-up
Change in other subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS (Symptoms, Sport and Recreation Function, and knee-related Quality of Life).
Time frame: Baseline, 2, 6 and 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Ahmed Farrag contact
Ahmed Farrag, PhD principal investigator
Prince Sultan Military College of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Standard Physcial Therapy, Intermittent Mechanical Traction and Continuous Mechanical Traction in people with Knee Osteoarthritis, run by Prince Sultan Military College of Health Sciences.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Farrag, PhD (+966 38440000 ext. 6941, afarrag@psmchs.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline, 2, 6 and 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2021.