- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05125289
Comparison of Soft Tissue Techniques on Hamstring Flexibility Knee Osteoarthritis
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Railway General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental intervention group 1
Graston technique group
|
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
|
|
Experimental: Experimental :interventional group II
Active release technique group
|
ART steps:
|
|
Experimental: experimental group III
Proprioceptive Neuromuscular Facilitation stretching group
|
PNF technique steps:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale (NPRS)
Time Frame: 4th week
|
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.
|
4th week
|
|
Active Knee Extension Test
Time Frame: 4th week
|
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.
|
4th week
|
|
Lower extremity functional index
Time Frame: 4th week
|
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.
|
4th week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiphahIU Ume habiba
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
-
Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
-
Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
I.M. Sechenov First Moscow State Medical UniversityRecruitingKnee Osteoarthritis | Knee Osteoarthritis in VarusRussia
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
Emory UniversityVertex Pharmaceuticals IncorporatedNot yet recruitingKnee Osteoarthritis | Knee ArthritisUnited States
-
VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
-
The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
Clinical Trials on Graston technique group
-
Riphah International UniversityCompletedTrigger PointsPakistan
-
Riphah International UniversityCompletedLateral EpicondylitisPakistan
-
Gazi UniversityRecruiting
-
University of Management and Technology Sialkot...CompletedScapulocostal SyndromePakistan
-
Riphah International UniversityCompleted
-
Superior UniversityActive, not recruitingTrapezius Muscle StrainPakistan
-
Riphah International UniversityCompleted
-
Superior UniversityNot yet recruitingKnee OsteoarthritisPakistan
-
Green International UniversityCompleted
-
Riphah International UniversityRecruitingTrigger Point Pain, MyofascialPakistan