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Mobilization Effect on Hamstring Length

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
knee joint mobilization and traction
Post isometric relaxation
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 Knee Mobilization, muscle length, knee Osteoarthritis

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Minimum 20% length shorting
  • NPRS more than 3
  • Gender include male and female
  • Age 40-65
  • Pain more than 3 months.
  • Patients with mild to moderate knee OA (primary and secondary) grade 1and 2 Kellgren and Lawrence classification system based on plain x-rays taken in supine lying position. They should satisfy the American College of Rheumatology Criteria for clinical classification of knee OA.

Hamstring shortness screening criteria: following tests should be positive for participants to enroll in this study

  • Active knee extension test
  • 90-90 test
  • Sit and reach test

Exclusion Criteria:

  • Co morbidities (i.e. Systematic diseases)
  • Patient on long-term Medications i.e. corticosteroid
  • Patient with Spinal Surgery
  • Recent trauma
  • Hamstring contracture.

Sites / Locations

  • Riphah International University Islamabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

knee joint mobilization and traction

Post isometric relaxation

Arm Description

Tibiofemoral, Tibiofibular joint anterioposterior mobilization, keltonborn knee traction Transcutaneous electrical nerve stimulation(TENS) and quadriceps strengthening

Post isometric relaxation on hamstring, TENS and quadriceps strengthening.

Outcomes

Primary Outcome Measures

Hamstring length: (Active Knee Extension Test)
Changes from the baseline to 12th day, this test is for to check hamstring flexibility, Patient position is in supine and effected leg is in 90 degree hip flexion. Patient is asked to extend the knee. Cutoff value for the Active knee extension test is 160.Normal individual presents with>160 or equal to160 (=160) and angle <160 considered hamstring tightness.

Secondary Outcome Measures

Numeric Pain rating scale (NPRS)
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain
WOMAC Scale
Changes from baseline WOMAC scale, it's a scale to evaluate the condition of patients with osteoarthritis of the knee, consisting of 24 items divided into 3 subscales including pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints.There are 5 responses to each question having a score assigned to it like None=0,slight=1,moderate=2,severe=3,extreme=4.scoring of this scale is done by sum up of all the points,minimum possible score is 0 while maximum possible score is 96.Higher number represents higher levels of disability.

Full Information

First Posted
September 19, 2020
Last Updated
December 16, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04574700
Brief Title
Mobilization Effect on Hamstring Length
Official Title
Effect of Knee Joint Mobilization on Hamstring Muscle Length
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (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
No

5. Study Description

Brief Summary
The aim of this research is to determine the effect of knee joint mobilization in patients with knee osteoarthritis having hamstring tightness. Tibiofemoral and tibiofibular joint mobilization and knee traction effect on hamstring muscle length and pain. A randomized controlled trial will be done at Benazir Bhutto Hospital Rawalpindi. The sample size is 44. The Participants are divided into two groups, 22 participants in experimental group and 22 in control group. The study duration is 6 months. Sampling technique applied is purposive non probability sampling technique, patients having Minimum 20% hamstring length shorting, NPRS more than 3,both gender of age 40-65,Pain more than 3 months and with mild to moderate knee OA are included. Tools used in this study are Numerical pain rating scale (NPRS), Goniometer and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale. Data analyzed through Statistical Package for the Social Science (SPSS)version 23.
Detailed Description
Knee Osteoarthritis is a type of joint disease or common rheumatologic disease that result from breakdown of joint cartilage and underlying bone which is characterized by pain, stiffness, and decreased range of motion. Knee OA is more important not only for its high prevalence rate compared with other types of OA but also for its presentation at earlier age groups particularly in younger age groups of obese women. Symptoms of knee OA progress slowly over years. The incidence of knee OA increases by age and further increase with longer lifetime and higher average weight of the population. Symptoms of knee OA progress slowly over years. Pain and other symptoms of OA may have a profound effect on quality of life affecting both physical function and psychological parameters. Knee OA is not a localized disease of cartilage alone but is considered as a chronic disease of the whole joint, including articular cartilage, meniscus, ligament, and peri-articular muscle that may result from multiple pathophysiological mechanisms. It is painful and disabling disease that affects millions of patients. Common symptoms are progressive knee stiffness, pain, difficulties in performing activities such as walking, stair climbing, squatting. Reduction in functional capacity associated with muscular imbalance of lower extremity with pain. Muscles act as brace for knee joint, quadriceps muscle weakness and hamstring inhibition effect this bracing. Muscle dysfunction may actually precede and accelerate the cartilage deterioration. Evidence showed muscle dysfunction is involved in pathogenesis of knee OA. Osteoarthritis (OA) is the most prevalent joint disease and a leading source of chronic pain and disability in the United States. Knee OA accounts for more than 80% of the disease's total burden and affects at least 19% of American adults aged 45 years and older. Clinical strategies exist for treatment of knee osteoarthritis with aim to reduce symptoms like pain, delay disease progression i.e. pharmacological, physiotherapy and surgical strategies. Patients experience chronic pain that cause reduction in ability to use their joint. Due to prolong inactivity of joint to move through complete range cause muscle shortness along with capsule tightness that leads for further increasing pain and disability. Physical therapy interventions are first line of choice for the treatment of knee OA. Treatment varieties i.e. modalities, therapeutic exercises, manual therapy along with neuromuscular training to improve mechanical environment of knee joint It is indicated at least 15-30 degree loss of active knee extension with 90 degree of hip flexion account as hamstring shortening. Hamstring muscle tightness and poor flexibility is associated with knee OA. Hamstring flexibility is higher in healthy individual as compared to subjects with knee OA.A statistically significant relationship was found between hamstring tightness and proximal tibiofibular joint grade of arthritis (χ2 test, p=0.004) Recent study reported 97.6% of middle aged men with hamstring muscle tightness Hamstring flexibility is greater in females than males. Research showed that ischio-tibial flexibility reduce pain stiffness and significant functional limitation in knee OA. Joint mobilizations are most widely used in treatment of knee OA having various neuro-physiological effects including decrease in pain, stiffness, activation and inhibition of muscles.The muscular system reflects sensorimotor system it receives information from musculoskeletal and central nervous systems. Changes occur in tone within the muscle are the first responses to nociception by the sensorimotor system. Many studies reported effect of joint pathology on muscle tone for example the presence of knee effusion causes reflex inhibition of the vastus-medialis and multifidus has been shown to atrophy in patients with chronic low back pain. In this study we aim to increase hamstring muscle length through activation of mechanoreceptors by mobilizations. There is no study conducted yet to determine effect of joint mobilization on adjacent muscle length other than soft tissue techniques which are mainly stretches. Literature review: randomized control trail (2019) conducted for comparing effectiveness on Proprioceptive Neuromuscular Facilitation(PNF) stretching verses static stretching on hamstring flexibility in knee OA patients showed PNF stretching was better in outcome measures A study compared static verses intermittent stretching for increase of hamstring muscle length concluded that intermittent stretching is more effective for hamstring flexibility. A pre-post study (2019) find out effect of unilateral posteroanterior mobilization(UPA) on lumbar spine observed in his study that UPA lumbar mobilizations increased lumbar Range of Motion and hamstring extensibility by a moderate magnitude and this effect remained for 10-15 minutes post treatment. Study reported Joint manipulations reduce nociceptor stimulus, depress responsiveness of alpha motor neurons causing changes in muscle tone. Study on active stretching and passive mobilization of cervical spine for neck pain concluded there was increase range of motion in both groups. comparing Muscle Energy Technique(MET) with conventional treatment for hamstring flexibility in knee OA patients reported that MET was better than conventional treatment. A randomized control trail(2014)compared immediate effects of neurodynamics slider technique verses static stretch concluded neurodynamics slider technique is more effective for improving hamstring flexibility. Therapeutic effect of joint mobilization that joint mobilization may promote muscles relaxation thereby increasing joint range of motion Joint mobilization and traction allows for selective stretching of selected tissue and can be expected to change both elastic and plastic component of stiffness. The intermittent compression and distraction of joint distribute fluid into soft tissue decreasing spasm allowing for easier movement and increase range of motion. Joint mobilization cause stimulation of Golgi tendon organ activity, and reflex inhibition of the muscle at the end of the passive joint mobilization. A study concluded that joint mobilization decreases muscle activity, reducing muscle concentric activation, pain, and muscle tension in periarticular-tissue

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Mobilization, muscle length, knee Osteoarthritis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
knee joint mobilization and traction
Arm Type
Experimental
Arm Description
Tibiofemoral, Tibiofibular joint anterioposterior mobilization, keltonborn knee traction Transcutaneous electrical nerve stimulation(TENS) and quadriceps strengthening
Arm Title
Post isometric relaxation
Arm Type
Active Comparator
Arm Description
Post isometric relaxation on hamstring, TENS and quadriceps strengthening.
Intervention Type
Other
Intervention Name(s)
knee joint mobilization and traction
Intervention Description
Grade 3 traction (Kaltenborn)from knee fully flexed to end of available Range of motion(ROM). Traction 30 sec, 10 sec rest period, 4reps, total 2 min of traction.3 sets for a total of 6 min of traction mobilization.Grade3 keltonborn tibiofemoral and tibiofibular anterior, posterior mobilization 3 sets10glides/set, 3 times/week on alternative days for 4 weeks. TENS for 20 mins in sitting and strengthening exercises i.e. Quadriceps Setting10 reps, air Cycling 2 min for a bout, straight leg raise (SLR) with weight , Full arc extension 10 reps of each exercise will be carried per session except for full-arc extension and air cycling. Air cycling cont. for 2 min for 1 bout of exercise. Measurement will be taken at base level, after first and last session. Treatment will be given for 3 times/week on alternative days for 4 weeks
Intervention Type
Other
Intervention Name(s)
Post isometric relaxation
Intervention Description
Control group include Post isometric relaxation technique on hamstring muscle will be performed in supine lying, hip flexed to 90 degrees knee extended until the point of resistance 20% of maximum effort will be used by patient to create isometric contraction. Patient will be asked to breathe in and hold for 5 to 8 seconds and release both breath and effort then move to new barrier point and process was repeated three times per session TENS and strengthening exercises as mentioned above. This treatment regime will be given for 3 times/week on alternative days for 4 weeks.
Primary Outcome Measure Information:
Title
Hamstring length: (Active Knee Extension Test)
Description
Changes from the baseline to 12th day, this test is for to check hamstring flexibility, Patient position is in supine and effected leg is in 90 degree hip flexion. Patient is asked to extend the knee. Cutoff value for the Active knee extension test is 160.Normal individual presents with>160 or equal to160 (=160) and angle <160 considered hamstring tightness.
Time Frame
12th day
Secondary Outcome Measure Information:
Title
Numeric Pain rating scale (NPRS)
Description
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain
Time Frame
12th day
Title
WOMAC Scale
Description
Changes from baseline WOMAC scale, it's a scale to evaluate the condition of patients with osteoarthritis of the knee, consisting of 24 items divided into 3 subscales including pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints.There are 5 responses to each question having a score assigned to it like None=0,slight=1,moderate=2,severe=3,extreme=4.scoring of this scale is done by sum up of all the points,minimum possible score is 0 while maximum possible score is 96.Higher number represents higher levels of disability.
Time Frame
12th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum 20% length shorting NPRS more than 3 Gender include male and female Age 40-65 Pain more than 3 months. Patients with mild to moderate knee OA (primary and secondary) grade 1and 2 Kellgren and Lawrence classification system based on plain x-rays taken in supine lying position. They should satisfy the American College of Rheumatology Criteria for clinical classification of knee OA. Hamstring shortness screening criteria: following tests should be positive for participants to enroll in this study Active knee extension test 90-90 test Sit and reach test Exclusion Criteria: Co morbidities (i.e. Systematic diseases) Patient on long-term Medications i.e. corticosteroid Patient with Spinal Surgery Recent trauma Hamstring contracture.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saira Waqqar, PPDPT,MHPE
Organizational Affiliation
Riphah international universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University Islamabad
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8153825
Citation
Hides JA, Stokes MJ, Saide M, Jull GA, Cooper DH. Evidence of lumbar multifidus muscle wasting ipsilateral to symptoms in patients with acute/subacute low back pain. Spine (Phila Pa 1976). 1994 Jan 15;19(2):165-72. doi: 10.1097/00007632-199401001-00009.
Results Reference
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Citation
Chen JG CE, Kim MK. Immediate Effect of Intermittent Versus Continuous Hamstring Static Stretching on the Muscle Tone and Range of Motion. 대한물리의학회지. 2019(14(4)):19-27
Results Reference
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Citation
N S. A comparative study on the effectiveness of PNF stretching versus static stretching on Pain and Hamstring flexibility in osteoarthritis knee patients. International Journal of Research in Pharmaceutical Sciences. 2019 Jul 12;10(3):1789-94
Results Reference
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PubMed Identifier
30935338
Citation
Chesterton P, Evans W, Livadas N, McLaren SJ. Time-course changes associated with PA lumbar mobilizations on lumbar and hamstring range of motion: a randomized controlled crossover trial. J Man Manip Ther. 2019 May;27(2):73-82. doi: 10.1080/10669817.2018.1542558. Epub 2018 Nov 13.
Results Reference
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Citation
Kim S-H, Choi J-H, Lee K-W. Immediate effects of active stretching versus passive mobilization of the upper cervical spine on patients with neck pain and ROM. Korean Society of Physical Medicine. 2016;11(4):27-32
Results Reference
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Citation
Choksi P TK. To Study the Efficacy of Muscle Energy Technique on Muscle Strength and Flexibility in Patients with Knee Osteoarthritis. . Indian Journal of Physiotherapy and Occupational Therapy-An International Journal. 2016;10((3)):40-5
Results Reference
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PubMed Identifier
26464889
Citation
Castellote-Caballero Y, Valenza MC, Puentedura EJ, Fernandez-de-Las-Penas C, Alburquerque-Sendin F. Immediate Effects of Neurodynamic Sliding versus Muscle Stretching on Hamstring Flexibility in Subjects with Short Hamstring Syndrome. J Sports Med (Hindawi Publ Corp). 2014;2014:127471. doi: 10.1155/2014/127471. Epub 2014 Apr 15.
Results Reference
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Citation
Kahanov L, Kato M. Therapeutic effect of joint mobilization: joint mechanoreceptors and nociceptors. Athletic Therapy Today. 2007;12(4):28-31
Results Reference
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PubMed Identifier
18796775
Citation
Randall T, Portney L, Harris BA. Effects of joint mobilization on joint stiffness and active motion of the metacarpal-phalangeal joint. J Orthop Sports Phys Ther. 1992;16(1):30-6. doi: 10.2519/jospt.1992.16.1.30.
Results Reference
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PubMed Identifier
25026443
Citation
Zusman M. Spinal manipulative therapy: review of some proposed mechanisms, and a new hypothesis. Aust J Physiother. 1986;32(2):89-99. doi: 10.1016/S0004-9514(14)60645-0.
Results Reference
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PubMed Identifier
215758
Citation
Lundberg A, Malmgren K, Schomburg ED. Role of joint afferents in motor control exemplified by effects on reflex pathways from Ib afferents. J Physiol. 1978 Nov;284:327-43. doi: 10.1113/jphysiol.1978.sp012543.
Results Reference
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Mobilization Effect on Hamstring Length

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