Knee OsteoarthritisNCT05125289
Comparison of Soft Tissue Techniques on Hamstring Flexibility Knee Osteoarthritis
A study testing Graston technique group, Active release technique group and Proprioceptive Neuromuscular Facilitation stretching group in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to compare the effects of Graston Technique, active release technique and PNF stretching on hamstring flexibility in Patients with Knee Osteoarthritis. Randomized controlled trials done at Riphah International University, Islamabad.. The sample size was 45. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Graston technique group, Active release technique group and Proprioceptive Neuromuscular Facilitation stretching group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 1 Aug 2022
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged > 30years. Both male \& female. Uni/bilateral OA. Grade I or II OA. Uni/bilateral hamstring tightness ranging between 40 to 70 degrees of a straight leg raise.
Who cannot join
- Hamstring injury and strains within 2 months. Any skin infections History of any lower limb surgeries within last 6 months. Lumber disc herniation. Lower limb neurological compromise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gender Based Comparison of Graston Technique, Active Release Technique and PNF Stretching on Hamstring Flexibility in Patients With Knee Osteoarthritis
The aim of this research is to compare the effects of Graston Technique, active release technique and PNF stretching on hamstring flexibility in Patients with Knee Osteoarthritis. Randomized controlled trials done at Riphah International University, Islamabad.. The sample size was 45. The subjects were divided in three groups, 15 subjects in Graston Technique group, 15 subjects in active release technique group and 15 in PNF stretching group. Study duration was of 6 months. Sampling technique applied was non probability purposive sampling technique. Male and female patients greater than 30 years of age, with unilateral or bilateral OA of grade 1 and 2 in Kellegren and Lawrence criteria for knee OA, having UL/BL hamstring tightness, Pain > 3 on NPRS, ROM > 200 from AKE test were included.
Tools used in the study are NPRS, AKE test by goniometer, Lower extremity functional index (LEFI) and WOMAC.
Read the detailed description
Osteoarthritis (OA) is the most common form of arthritis, affecting an estimated 302 million people worldwide. It is expected that ten percent males and 18 percent females have knee or hip OA. It ranks as the fifth highest cause of years lost to disability in the whole population in high-income countries, and the ninth highest cause in low- and middle-income countries. In older people, OA is the utmost devastating musculoskeletal syndrome.
It is a long-term chronic disease characterized by the destruction of articular cartilage and underlying bone. The degeneration occurs due to disarrangement in the usual process of repair of a joint. When the process breaks the synchronicity, there is slow deterioration of the articular cartilage. As a result, the biomechanical influences on the joints are also changed due to loss of normal joint line of gravity. This ultimately leads toward symptomatic changes which are a focal loss of the cartilage covering the articular ends; loss of normal joint space requires for smooth grating, osteophyte formation in joint, and remoulding of bone on peripheral areas and along the articular sides. Signs and symptoms are pain, a restricted range of joint movement, reduced muscle strength, restricted activities of daily living (ADLs) and instrumental activities of daily living (IADLS), and reduced quality of life.
Exercise, weight loss in patients with knee and/or hip OA who are overweight or obese, self-efficacy and self-management programs, tai chi, cane use, hand orthoses for first carpometacarpal (CMC) joint OA, tibiofemoral bracing for tibiofemoral knee OA, topical nonsteroidal anti-inflammatory drugs (NSAIDs) for knee OA, oral NSAIDs, and intraarticular glucocorticoid injections for knee OA are strongly recommended for treatment purposes. One major problem for patients with knee OA is poor hamstring flexibility. The stretching of the hamstring is a necessary intervention in the management of the OA knee. Although research and clinical experience has shown that treatment of hamstring flexibility is important, there is no widely acceptable form of treatment that is agreed upon to successfully improve flexibility of hamstrings.
Instrument assisted soft tissue mobilization (IASTM) using Graston technique is a popular treatment for myofascial restriction. The IASTM treatment is thought to stimulate connective tissue remodeling through resorption of excessive fibrosis, along with inducing repair and regeneration of collagen secondary to fibroblast recruitment. In turn, this will result in the release and breakdown of scar tissue, adhesions, and fascial restrictions.
Active release technique (ART) is also a technique that involves breaking down adhesions and scar tissue which cause pain and dysfunctions. It involves a clinician using their thumbs or fingers to apply deep tension to a trigger point while the involved tissue is moved from a shortened to lengthened position both actively by the patient and passively by the clinician.
Proprioceptive Neuromuscular Facilitation (PNF) stretching technique is another technique utilized to improve muscle elasticity. This technique is specifically designed to stimulate mechanoreceptors and significant effect of static as well as PNF stretching on clinical symptoms of knee OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Graston technique group, Active release technique group, Proprioceptive Neuromuscular Facilitation stretching group
- Keywords
- Active release technique, Graston technique, Knee Osteoarthritis, PNF stretching, Hamstring tightness
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graston technique groupOther
Moist hot pack (10 minutes) Isometric quadriceps exercises (10 repetitions) Straight leg raise (10 repetitions) Graston technique steps 6 long strokes by the GT1 instrument on the hamstring muscle longitudinally. The Graston technique duration will be 5 minutes
Active release technique groupOther
- Moist hot pack (10 minutes)
- Isometric quadriceps exercises (10 repetitions)
- Straight leg raise (10 repetitions)
ART steps:
- Subject lies on the plinth in prone or in side lying position with the dominant side facing upwards.
- Gentle tension is applied to the hamstring muscle along the entire length while stretching the leg in prone lying or side lying positions, depending on the level of pain and tightness of muscle (5 repetitions at 5 seconds interval).
- Gentle tension is also applied at the origin and insertion of the hamstring muscle until the patient feels full release.
Proprioceptive Neuromuscular Facilitation stretching groupOther
- Moist hot pack (10 minutes)
- Isometric quadriceps exercises (10 repetitions)
- Straight leg raise (10 repetitions)
PNF technique steps:
- The subject is in supine position with his non-dominant leg strapped down the table while the dominant leg rests on the therapist right shoulder.
- The therapist stretches the hamstring muscle until the subject first reports a mild stretch sensation; held for 7 sec by passively flexing the hip with knee fully extended, allowing no hip rotation.
- Next, the subject isometrically contracts the hamstring muscle for 3 sec and then relax for 5 sec.
- This sequence is repeated 5 times at a 20 second interval.
| Study group | Role | What they receive |
|---|---|---|
| experimental intervention group 1 | Experimental | Graston technique group Receives: Other: Graston technique group |
| Experimental :interventional group II | Experimental | Active release technique group Receives: Other: Active release technique group |
| experimental group III | Experimental | Proprioceptive Neuromuscular Facilitation stretching group Receives: Other: Proprioceptive Neuromuscular Facilitation stretching group |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
WOMAC was used for evaluating Osteoarthritis patients. The WOMAC OA index included 24 questions and three sections that questioned pain, stiffness, and physical function. The scale included five pain-related questions, two stiffness-related questions, and 17 physical function- related questions. The maximum scores were 20 for the pain subgroup, eight for the stiffness subgroup and 68 for the physical function subgroup. High scores indicated that the patient had worse symptoms in the relevant group.
Measured: 4th week
Secondary outcomes (3)
Numeric pain rating scale (NPRS)
NPRS was used for one-dimensional pain measurement It was an 11-item scale in which respondents selected the whole number from 0 to 10 to best describe their pain intensity in the last 24 hours. 0 represented no pain and 10 represented the worst possible pain experienced by the respondent. It had a reliability of 0.96 in literate and 0.95 in illiterate patients and had 0.86 - 0.95 validity.
Measured: 4th week
Active Knee Extension Test
The AKET measured hamstring muscle length. In the AKET, the patient actively extended the knee until reaching maximal stretch of the hamstring while the ipsilateral hip was kept at a fixed angle, usually 90 or 120 degrees of flexion.
Measured: 4th week
Lower extremity functional index
The lower extremity functional scale is a well-known and validated patient-rated outcome measure (PROM) that was used to measure lower extremity function. The score consisted of 20 questions, which were subdivided into 4 groups. These groups consisted of activities with increasing physical demands. Questions on activity varied from walking between rooms to running on uneven ground.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Dec 2021
- Primary completion20 Jul 2022
- Study completion1 Aug 2022
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125289
- Sponsor's protocol ID
- RiphahIU Ume habiba
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Based Comparison of Graston Technique, Active Release Technique and PNF Stretching on Hamstring Flexibility in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05125289
- Acronym / sponsor ID
- RiphahIU Ume habiba
- Conditions
- Knee Osteoarthritis
- Keywords
- Active release technique, Graston technique, Knee Osteoarthritis, PNF stretching, Hamstring tightness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 18 Nov 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.
The aim of this research is to compare the effects of Graston Technique, active release technique and PNF stretching on hamstring flexibility in Patients with Knee Osteoarthritis. Randomized controlled trials done at Riphah International University, Islamabad.. The sample size was 45. The subjects were divided in three groups, 15 subjects in Graston Technique group, 15 subjects in active release technique group and 15 in PNF stretching group. Study duration was of 6 months. Sampling technique applied was non probability purposive sampling technique. Male and female patients greater than 30 years of age, with unilateral or bilateral OA of grade 1 and 2 in Kellegren and Lawrence criteria for knee OA, having UL/BL hamstring tightness, Pain > 3 on NPRS, ROM > 200 from AKE test were included.
Tools used in the study are NPRS, AKE test by goniometer, Lower extremity functional index (LEFI) and WOMAC.
Detailed description
Osteoarthritis (OA) is the most common form of arthritis, affecting an estimated 302 million people worldwide. It is expected that ten percent males and 18 percent females have knee or hip OA. It ranks as the fifth highest cause of years lost to disability in the whole population in high-income countries, and the ninth highest cause in low- and middle-income countries. In older people, OA is the utmost devastating musculoskeletal syndrome.
It is a long-term chronic disease characterized by the destruction of articular cartilage and underlying bone. The degeneration occurs due to disarrangement in the usual process of repair of a joint. When the process breaks the synchronicity, there is slow deterioration of the articular cartilage. As a result, the biomechanical influences on the joints are also changed due to loss of normal joint line of gravity. This ultimately leads toward symptomatic changes which are a focal loss of the cartilage covering the articular ends; loss of normal joint space requires for smooth grating, osteophyte formation in joint, and remoulding of bone on peripheral areas and along the articular sides. Signs and symptoms are pain, a restricted range of joint movement, reduced muscle strength, restricted activities of daily living (ADLs) and instrumental activities of daily living (IADLS), and reduced quality of life.
Exercise, weight loss in patients with knee and/or hip OA who are overweight or obese, self-efficacy and self-management programs, tai chi, cane use, hand orthoses for first carpometacarpal (CMC) joint OA, tibiofemoral bracing for tibiofemoral knee OA, topical nonsteroidal anti-inflammatory drugs (NSAIDs) for knee OA, oral NSAIDs, and intraarticular glucocorticoid injections for knee OA are strongly recommended for treatment purposes. One major problem for patients with knee OA is poor hamstring flexibility. The stretching of the hamstring is a necessary intervention in the management of the OA knee. Although research and clinical experience has shown that treatment of hamstring flexibility is important, there is no widely acceptable form of treatment that is agreed upon to successfully improve flexibility of hamstrings.
Instrument assisted soft tissue mobilization (IASTM) using Graston technique is a popular treatment for myofascial restriction. The IASTM treatment is thought to stimulate connective tissue remodeling through resorption of excessive fibrosis, along with inducing repair and regeneration of collagen secondary to fibroblast recruitment. In turn, this will result in the release and breakdown of scar tissue, adhesions, and fascial restrictions.
Active release technique (ART) is also a technique that involves breaking down adhesions and scar tissue which cause pain and dysfunctions. It involves a clinician using their thumbs or fingers to apply deep tension to a trigger point while the involved tissue is moved from a shortened to lengthened position both actively by the patient and passively by the clinician.
Proprioceptive Neuromuscular Facilitation (PNF) stretching technique is another technique utilized to improve muscle elasticity. This technique is specifically designed to stimulate mechanoreceptors and significant effect of static as well as PNF stretching on clinical symptoms of knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental intervention group 1 | Experimental | Other: Graston technique groupGraston technique group |
| Experimental :interventional group II | Experimental | Other: Active release technique groupActive release technique group |
| experimental group III | Experimental | Other: Proprioceptive Neuromuscular Facilitation stretching groupProprioceptive Neuromuscular Facilitation stretching group |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged > 30years. Both male \& female. Uni/bilateral OA. Grade I or II OA. Uni/bilateral hamstring tightness ranging between 40 to 70 degrees of a straight leg raise.
Key exclusion criteria (1 listed)
- Hamstring injury and strains within 2 months. Any skin infections History of any lower limb surgeries within last 6 months. Lumber disc herniation. Lower limb neurological compromise.
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 |
|---|---|---|
| Graston technique groupMoist hot pack (10 minutes) Isometric quadriceps exercises (10 repetitions) Straight leg raise (10 repetitions) Graston technique steps 6 long strokes by the GT1 instrument on the hamstring muscle longitudinally. The Graston technique duration will be 5 minutes | Other | experimental intervention group 1 |
| Active release technique group* Moist hot pack (10 minutes) * Isometric quadriceps exercises (10 repetitions) * Straight leg raise (10 repetitions) ART steps: * Subject lies on the plinth in prone or in side lying position with the dominant side facing upwards. * Gentle tension is applied to the hamstring muscle along the entire length while stretching the leg in prone lying or side lying positions, depending on the level of pain and tightness of muscle (5 repetitions at 5 seconds interval). * Gentle tension is also applied at the origin and insertion of the hamstring muscle until the patient feels full release. | Other | Experimental :interventional group II |
| Proprioceptive Neuromuscular Facilitation stretching group* Moist hot pack (10 minutes) * Isometric quadriceps exercises (10 repetitions) * Straight leg raise (10 repetitions) PNF technique steps: * The subject is in supine position with his non-dominant leg strapped down the table while the dominant leg rests on the therapist right shoulder. * The therapist stretches the hamstring muscle until the subject first reports a mild stretch sensation; held for 7 sec by passively flexing the hip with knee fully extended, allowing no hip rotation. * Next, the subject isometrically contracts the hamstring muscle for 3 sec and then relax for 5 sec. * This sequence is repeated 5 times at a 20 second interval. | Other | experimental group III |
Primary outcome
WOMAC
Time frame: 4th week
WOMAC was used for evaluating Osteoarthritis patients. The WOMAC OA index included 24 questions and three sections that questioned pain, stiffness, and physical function. The scale included five pain-related questions, two stiffness-related questions, and 17 physical function- related questions. The maximum scores were 20 for the pain subgroup, eight for the stiffness subgroup and 68 for the physical function subgroup. High scores indicated that the patient had worse symptoms in the relevant group.
3 secondary outcomes
Numeric pain rating scale (NPRS)
Time frame: 4th week
Active Knee Extension Test
Time frame: 4th week
Lower extremity functional index
Time frame: 4th week
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 9 Nov 2022.
- 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.
Aisha Razzaq, MSPT-OMPT 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 Graston technique group, Active release technique group and Proprioceptive Neuromuscular Facilitation stretching group 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 1 inclusion and 1 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 9 Nov 2022. 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?
WOMAC (time frame: 4th week). 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 9 Nov 2022.