NCT04574700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

September 19, 2020

Last Update Submit

December 16, 2020

Conditions

Keywords

Knee Mobilizationmuscle lengthknee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    12th day

Secondary Outcomes (2)

  • Numeric Pain rating scale (NPRS)

    12th day

  • WOMAC Scale

    12th day

Study Arms (2)

knee joint mobilization and traction

EXPERIMENTAL

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

Other: knee joint mobilization and traction

Post isometric relaxation

ACTIVE COMPARATOR

Post isometric relaxation on hamstring, TENS and quadriceps strengthening.

Other: Post isometric relaxation

Interventions

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

knee joint mobilization and traction

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.

Post isometric relaxation

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • test
  • Sit and reach test

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University Islamabad

Islamabad, Punjab Province, 44000, Pakistan

Location

Related Publications (11)

  • 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.

    PMID: 8153825BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 30935338BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 26464889BACKGROUND
  • Kahanov L, Kato M. Therapeutic effect of joint mobilization: joint mechanoreceptors and nociceptors. Athletic Therapy Today. 2007;12(4):28-31

    BACKGROUND
  • 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.

    PMID: 18796775BACKGROUND
  • 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.

    PMID: 25026443BACKGROUND
  • 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.

    PMID: 215758BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Traction

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Saira Waqqar, PPDPT,MHPE

    Riphah international universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2020

First Posted

October 5, 2020

Study Start

January 1, 2020

Primary Completion

December 15, 2020

Study Completion

December 15, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations