Knee OsteoarthritisNCT05723029
Bowen Technique and Post Isometric Relaxation in Knee Osteoarthritis Patients
A study testing Bowen Technique and Post Isometric Relaxation in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The Hamstring muscles are present at the posterior surface of the thigh. The muscles start in the gluteal region and run back of the thigh and insert into the popliteal fossa. The function of hamstring muscles flexes the knee and extension of the thigh. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Bowen Technique and Post Isometric Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jan 2023to 31 Mar 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic subjects with hamstring tightness
- Both male and female
- Age between 45 to 65
- O degree to 20-degree active knee extension loss
- Subject with inter-articular knee joint pathology
- Diagnosed osteoarthritis patients
- Grade 1 to 4 Osteoarthritis
Who cannot join
- Subject history of lower extremity injury
- Any Neurological symptoms or radiating pain
- Any lower limb deformity
- Any fracture or Surgery is done for knee
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Al-Mustafa Medical and Physiotherapy Center
Lahore, Punjab Province, 54000
About this study
Official title: Comparative Effects of Bowen Technique and Post Isometric Relaxation on Pain, Range of Motion and Hamstring Flexibility in Knee Osteoarthritis Patients
The Hamstring muscles are present at the posterior surface of the thigh. The muscles start in the gluteal region and run back of the thigh and insert into the popliteal fossa. The function of hamstring muscles flexes the knee and extension of the thigh. In degenerative joint disease, muscles tightness of the lower extremity leads to a decrease in joint flexibility. In knee joint osteoarthritis, hamstring muscles are more prone to tightness. The objective of this study is to compare the effects of the Bowen technique and Post Isometric Relaxation on pain, range of motion, and hamstring flexibility in knee osteoarthritis patients.
Read the detailed description
This study will be a randomized clinical trial and will be conducted at Al- Mustafa Medical and Physiotherapy Center. The study will be completed within the time duration of six months. For data collection, a convenient sampling technique will be used. The Population will be diagnosed with osteoarthritis patients. A sample size of total 24 patients will be taken in this study. The measurement tool will be Active knee extension test, Goniometer and Numeric pain rating scale. The pre-test and post-test outcome measurement will be taken. Patients will be divided into two groups. Group A will receive the Bowen technique intervention and Group B will receive the Post Isometric Relaxation technique. The interventions groups will receive three sessions per week for 4 weeks.
- Conditions
- Knee Osteoarthritis
- Being tested
- Bowen Technique, Post Isometric Relaxation
- Keywords
- Post Isometric Relaxation, Bowen Technique, Hamstring muscle flexibility, 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.
Bowen TechniqueOther
A Bowen moves challenges the muscles for several seconds by the application of a gentle lateral pressure applied by the therapist thumb, against its medial edge. The muscle fibres and its fascia are disturbed from their neutral position and they are slightly stretched. The therapist apply gentle pressure towards the muscles using the skin slack available, and then rolls the thumb across the muscles and gently compressing it, the muscle will bounce back to its original position.
Post Isometric RelaxationOther
Post Isometric Relaxation is performed in supine position on treatment table. The therapist passively flexed the hip and knee at the 90 degrees and then passively extends the knee until the point of tissue resistance. Patient placed their leg on therapist shoulder and contracts his hamstring muscles by pushing down on the therapist shoulder for 10 seconds. After the contraction, patient is asked to relax, then therapist passively stretch to gain new range of muscles.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Bowen Technique | Experimental | The subjects will receive Bowen Technique. The treatment session will be 3 times per week for 4 weeks for 20 minutes. The Bowen technique is a subtle and precise mobilization called Bowen moves. The mobilization is applied by using the fingers and thumbs over muscles, tendon, nerves and fascia. Only gentle non-invasive pressure is applied. A Bowen moves challenges the muscles for several seconds by the application of a gentle lateral pressure applied by the therapist thumb, against its medial edge. The muscle fibres and its fascia are disturbed from their neutral position and they are slightly stretched. The therapist apply gentle pressure towards the muscles using the skin slack available, and then rolls the thumb across the muscles and gently compressing it, the muscle will bounce back to its original position. The therapist has a sense of tissue tension, and this enables his/her to feel where stress has built up in the tissue. Receives: Other: Bowen Technique |
| Group B: Post Isometric Relaxation Technique | Experimental | The subjects will receive Post Isometric Relaxation Technique. Treatment session includes 3 times per week for 4 weeks for 20 minutes. Evaluation will be done before and after the treatment at the end of the 4th week. The outcome will be measured by the Active Knee Extension test, Numeric pain Rating Scale, and Goniometer. Post Isometric Relaxation is performed in supine position on treatment table. The therapist passively flexed the hip and knee at the 90 degrees and then passively extends the knee until the point of tissue resistance. Patient placed their leg on therapist shoulder and contracts his hamstring muscles by pushing down on the therapist shoulder for 10 seconds. After the contraction, patient is asked to relax, then therapist passively stretch to gain new range of muscles. The intervention is performed three times in a single session with 30 seconds rest intervals. Receives: Other: Post Isometric Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Active knee extension test
In this test, the subject is on the left-side lying on the examination table for bony landmark identification. The lateral femoral condyle, head of a fibula, and lateral malleolus of the right leg are marked to ensure that the same reference point is used for repeated measurement. When the landmarks are identified, the subject is instructed to lie in the supine position. The subject flexes the right hip at 90 degrees and grasps behind the right knee to stabilize the hip at 90 degrees. A goniometer is used to position the right knee at 90 degrees. A stationary arm long lateral femur and movable arm aligned with lateral fibula keeping lateral femoral condyle as an axis. The Patient actively extends the right knee as much as possible without moving the thigh from a vertical position. The active Range of motion of the knee is measured by a goniometer. (7) The active knee extension test have excellent intra-rater reliability(r = .7).
Measured: Baseline measurement (Pre-Treatment) in start on 1st day and post treatment follow-up for change will be taken on 4th week
Change in Numeric pain rating scale
The Numeric pain rating scale is a self-reported measurement tool consisting of a numerical point scale. The scale is set up on a horizontal or vertical line, which ranges most commonly from 0 to 10, where 0 is no pain and 10 is the worst pain. The patient is asked to rate his or her pain intensity. There are three categories of pain least pain, average pain and, worst pain. The test-retest reliability for the Numeric pain rating scale varies from 0.67 to 0.96.
Measured: Baseline measurement (Pre-Treatment) in start at at 1st week and post treatment follow-up for change will be taken on4th week
Change in Goniometer test
In this test, each subject is in the supine position, while a small pillow is placed beneath his head and neck. Then the legs and thighs of the other lower extremity are fixed to the bed with a strap. The knee flexion axis is being marked by a pen and from this point; a line is being drawn to the greater trochanter of the femur and one other line to the external malleolus of the ankle. These lines are used to measure the knee joint angles. The goniometer axis is placed on the knee axis and its arm is the place along with the line drawn on the thigh and the other arm is placed along with the line drawn on the leg. The Hip joint is 90 degrees and the vertical position of the thigh is being maintained. The subject is asked to do the active Knee extension slowly while the ankle is in the neutral position.
Measured: Baseline measurement (Pre-Treatment) in start on 1st day and post treatment follow-up for change will be taken on 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start18 Jan 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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 Knee OsteoarthritisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723029
- Sponsor's protocol ID
- REC/RCR & AHS/22/0156
- Status last verified
- Apr 2023
- First submitted
- 24 Jan 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kahl C, Cleland JA. Visual analogue scale, numeric pain rating scale and the McGill Pain Questionnaire: an overview of psychometric properties. Physical therapy reviews. 2005;10(2):123-8.
Shamsi M, Mirzaei M, Khabiri SS. Universal goniometer and electro-goniometer intra-examiner reliability in measuring the knee range of motion during active knee extension test in patients with chronic low back pain with short hamstring muscle. BMC Sports Sci Med Rehabil. 2019 Mar 22;11:4. doi: 10.1186/s13102-019-0116-x. eCollection 2019.
PubMed 30949343Neto T, Jacobsohn L, Carita AI, Oliveira R. Reliability of the Active-Knee-Extension and Straight-Leg-Raise Tests in Subjects With Flexibility Deficits. J Sport Rehabil. 2015 Dec 3;24(4):2014-0220. doi: 10.1123/jsr.2014-0220. Print 2015 Nov 1.
PubMed 25364856Khuman PR, Surbala L, Patel P, Chavda D. Immediate effects of single session post isometric relaxation muscle energy technique versus mulligan's bent leg raise technique on pain and hamstring flexibility in knee osteoarthritis participants: A randomised controlled study. Physiotherapy. 2014;3(9):324-35.
Masekar MB, Rayjade DA, Yadav DT, Chotai DK. Effectiveness of Muscle Energy Technique and Proprioceptive Neuromuscular Facilitation in Knee Osteoarthritis.(2021). Int J Life SciPharmaRes.11(1):L16- 22.
Marr M, Baker J, Lambon N, Perry J. The effects of the Bowen technique on hamstring flexibility over time: a randomised controlled trial. J Bodyw Mov Ther. 2011 Jul;15(3):281-90. doi: 10.1016/j.jbmt.2010.07.008. Epub 2010 Sep 15.
PubMed 21665103
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Bowen Technique and Post Isometric Relaxation on Pain, Range of Motion and Hamstring Flexibility in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT05723029
- Acronym / sponsor ID
- REC/RCR & AHS/22/0156
- Conditions
- Knee Osteoarthritis
- Keywords
- Post Isometric Relaxation, Bowen Technique, Hamstring muscle flexibility, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 10 Feb 2023 (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.
The Hamstring muscles are present at the posterior surface of the thigh. The muscles start in the gluteal region and run back of the thigh and insert into the popliteal fossa. The function of hamstring muscles flexes the knee and extension of the thigh. In degenerative joint disease, muscles tightness of the lower extremity leads to a decrease in joint flexibility. In knee joint osteoarthritis, hamstring muscles are more prone to tightness. The objective of this study is to compare the effects of the Bowen technique and Post Isometric Relaxation on pain, range of motion, and hamstring flexibility in knee osteoarthritis patients.
Detailed description
This study will be a randomized clinical trial and will be conducted at Al- Mustafa Medical and Physiotherapy Center. The study will be completed within the time duration of six months. For data collection, a convenient sampling technique will be used. The Population will be diagnosed with osteoarthritis patients. A sample size of total 24 patients will be taken in this study. The measurement tool will be Active knee extension test, Goniometer and Numeric pain rating scale. The pre-test and post-test outcome measurement will be taken. Patients will be divided into two groups. Group A will receive the Bowen technique intervention and Group B will receive the Post Isometric Relaxation technique. The interventions groups will receive three sessions per week for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Bowen Technique | Experimental | Other: Bowen TechniqueThe subjects will receive Bowen Technique. The treatment session will be 3 times per week for 4 weeks for 20 minutes. The Bowen technique is a subtle and precise mobilization called Bowen moves. The mobilization is applied by using the fingers and thumbs over muscles, tendon, nerves and fascia. Only gentle non-invasive pressure is applied. A Bowen moves challenges the muscles for several seconds by the application of a gentle lateral pressure applied by the therapist thumb, against its medial edge. The muscle fibres and its fascia are disturbed from their neutral position and they are slightly stretched. The therapist apply gentle pressure towards the muscles using the skin slack available, and then rolls the thumb across the muscles and gently compressing it, the muscle will bounce back to its original position. The therapist has a sense of tissue tension, and this enables his/her to feel where stress has built up in the tissue. |
| Group B: Post Isometric Relaxation Technique | Experimental | Other: Post Isometric RelaxationThe subjects will receive Post Isometric Relaxation Technique. Treatment session includes 3 times per week for 4 weeks for 20 minutes. Evaluation will be done before and after the treatment at the end of the 4th week. The outcome will be measured by the Active Knee Extension test, Numeric pain Rating Scale, and Goniometer. Post Isometric Relaxation is performed in supine position on treatment table. The therapist passively flexed the hip and knee at the 90 degrees and then passively extends the knee until the point of tissue resistance. Patient placed their leg on therapist shoulder and contracts his hamstring muscles by pushing down on the therapist shoulder for 10 seconds. After the contraction, patient is asked to relax, then therapist passively stretch to gain new range of muscles. The intervention is performed three times in a single session with 30 seconds rest intervals. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Symptomatic subjects with hamstring tightness
- Both male and female
- Age between 45 to 65
- O degree to 20-degree active knee extension loss
- Subject with inter-articular knee joint pathology
Key exclusion criteria (4 listed)
- Subject history of lower extremity injury
- Any Neurological symptoms or radiating pain
- Any lower limb deformity
- Any fracture or Surgery is done for knee
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 |
|---|---|---|
| Bowen TechniqueA Bowen moves challenges the muscles for several seconds by the application of a gentle lateral pressure applied by the therapist thumb, against its medial edge. The muscle fibres and its fascia are disturbed from their neutral position and they are slightly stretched. The therapist apply gentle pressure towards the muscles using the skin slack available, and then rolls the thumb across the muscles and gently compressing it, the muscle will bounce back to its original position. | Other | Group A: Bowen Technique |
| Post Isometric RelaxationPost Isometric Relaxation is performed in supine position on treatment table. The therapist passively flexed the hip and knee at the 90 degrees and then passively extends the knee until the point of tissue resistance. Patient placed their leg on therapist shoulder and contracts his hamstring muscles by pushing down on the therapist shoulder for 10 seconds. After the contraction, patient is asked to relax, then therapist passively stretch to gain new range of muscles. | Other | Group B: Post Isometric Relaxation Technique |
Primary outcome
Change in Active knee extension test
Time frame: Baseline measurement (Pre-Treatment) in start on 1st day and post treatment follow-up for change will be taken on 4th week
In this test, the subject is on the left-side lying on the examination table for bony landmark identification. The lateral femoral condyle, head of a fibula, and lateral malleolus of the right leg are marked to ensure that the same reference point is used for repeated measurement. When the landmarks are identified, the subject is instructed to lie in the supine position. The subject flexes the right hip at 90 degrees and grasps behind the right knee to stabilize the hip at 90 degrees. A goniometer is used to position the right knee at 90 degrees. A stationary arm long lateral femur and movable arm aligned with lateral fibula keeping lateral femoral condyle as an axis. The Patient actively extends the right knee as much as possible without moving the thigh from a vertical position. The active Range of motion of the knee is measured by a goniometer. (7) The active knee extension test have excellent intra-rater reliability(r = .7).
Change in Numeric pain rating scale
Time frame: Baseline measurement (Pre-Treatment) in start at at 1st week and post treatment follow-up for change will be taken on4th week
The Numeric pain rating scale is a self-reported measurement tool consisting of a numerical point scale. The scale is set up on a horizontal or vertical line, which ranges most commonly from 0 to 10, where 0 is no pain and 10 is the worst pain. The patient is asked to rate his or her pain intensity. There are three categories of pain least pain, average pain and, worst pain. The test-retest reliability for the Numeric pain rating scale varies from 0.67 to 0.96.
Change in Goniometer test
Time frame: Baseline measurement (Pre-Treatment) in start on 1st day and post treatment follow-up for change will be taken on 4th week
In this test, each subject is in the supine position, while a small pillow is placed beneath his head and neck. Then the legs and thighs of the other lower extremity are fixed to the bed with a strap. The knee flexion axis is being marked by a pen and from this point; a line is being drawn to the greater trochanter of the femur and one other line to the external malleolus of the ankle. These lines are used to measure the knee joint angles. The goniometer axis is placed on the knee axis and its arm is the place along with the line drawn on the thigh and the other arm is placed along with the line drawn on the leg. The Hip joint is 90 degrees and the vertical position of the thigh is being maintained. The subject is asked to do the active Knee extension slowly while the ankle is in the neutral position.
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 19 Apr 2023.
- BackgroundKahl C, Cleland JA. Visual analogue scale, numeric pain rating scale and the McGill Pain Questionnaire: an overview of psychometric properties. Physical therapy reviews. 2005;10(2):123-8.
- Background: PubMed 30949343Shamsi M, Mirzaei M, Khabiri SS. Universal goniometer and electro-goniometer intra-examiner reliability in measuring the knee range of motion during active knee extension test in patients with chronic low back pain with short hamstring muscle. BMC Sports Sci Med Rehabil. 2019 Mar 22;11:4. doi: 10.1186/s13102-019-0116-x. eCollection 2019.
- Background: PubMed 25364856Neto T, Jacobsohn L, Carita AI, Oliveira R. Reliability of the Active-Knee-Extension and Straight-Leg-Raise Tests in Subjects With Flexibility Deficits. J Sport Rehabil. 2015 Dec 3;24(4):2014-0220. doi: 10.1123/jsr.2014-0220. Print 2015 Nov 1.
- BackgroundKhuman PR, Surbala L, Patel P, Chavda D. Immediate effects of single session post isometric relaxation muscle energy technique versus mulligan's bent leg raise technique on pain and hamstring flexibility in knee osteoarthritis participants: A randomised controlled study. Physiotherapy. 2014;3(9):324-35.
- BackgroundMasekar MB, Rayjade DA, Yadav DT, Chotai DK. Effectiveness of Muscle Energy Technique and Proprioceptive Neuromuscular Facilitation in Knee Osteoarthritis.(2021). Int J Life SciPharmaRes.11(1):L16- 22.
- Background: PubMed 21665103Marr M, Baker J, Lambon N, Perry J. The effects of the Bowen technique on hamstring flexibility over time: a randomised controlled trial. J Bodyw Mov Ther. 2011 Jul;15(3):281-90. doi: 10.1016/j.jbmt.2010.07.008. Epub 2010 Sep 15.
- 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.
Samrood Akram, Mphil 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 Bowen Technique and Post Isometric Relaxation in people with Knee Osteoarthritis, 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 7 inclusion and 4 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 19 Apr 2023. 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?
Change in Active knee extension test (time frame: Baseline measurement (Pre-Treatment) in start on 1st day and post treatment follow-up for change will be taken on 4th week). 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 NCT05723029, 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 19 Apr 2023.