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Comparison of Soft Tissue Techniques on Hamstring Flexibility Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Graston technique group
Active release technique group
Proprioceptive Neuromuscular Facilitation stretching group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Active release technique, Graston technique, Knee Osteoarthritis, PNF stretching, Hamstring tightness

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Railway General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

experimental intervention group 1

Experimental :interventional group II

experimental group III

Arm Description

Graston technique group

Active release technique group

Proprioceptive Neuromuscular Facilitation stretching group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 8, 2021
Last Updated
November 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05125289
Brief Title
Comparison of Soft Tissue Techniques on Hamstring Flexibility Knee Osteoarthritis
Official Title
Gender Based Comparison of Graston Technique, Active Release Technique and PNF Stretching on Hamstring Flexibility in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Active release technique, Graston technique, Knee Osteoarthritis, PNF stretching, Hamstring tightness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental intervention group 1
Arm Type
Experimental
Arm Description
Graston technique group
Arm Title
Experimental :interventional group II
Arm Type
Experimental
Arm Description
Active release technique group
Arm Title
experimental group III
Arm Type
Experimental
Arm Description
Proprioceptive Neuromuscular Facilitation stretching group
Intervention Type
Other
Intervention Name(s)
Graston technique group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Active release technique group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation stretching group
Intervention Description
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.
Primary Outcome Measure Information:
Title
WOMAC
Description
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.
Time Frame
4th week
Secondary Outcome Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
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.
Time Frame
4th week
Title
Active Knee Extension Test
Description
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.
Time Frame
4th week
Title
Lower extremity functional index
Description
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.
Time Frame
4th week

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aisha Razzaq, MSPT-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Soft Tissue Techniques on Hamstring Flexibility Knee Osteoarthritis

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