NCT06855303

Brief Summary

The current study will compare the effect of using the muscle energy technique in 2 different methods on the hamstring muscle flexibility

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

December 2, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

February 25, 2025

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • The Numeric Pain Rating

    The numeric pain rating Scale (NPRS) is the simplest and most commonly used numeric scale to rate the pain from 0 (no pain) to 10 (worst pain). The NPRS will be used for subjective pain measurement that has good test-retest reliability.

    From baseline to the end of the treatment at 6 weeks

  • The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure symptoms and physical disability, originally developed for people with OA of the hip or knee. It evaluates three dimensions: pain, stiffness, and physical function

    From baseline to the end of the treatment at 6 months

  • Sit and reach test

    The Sit and reach test is one of the linear flexibility tests that helps to measure flexibility of the lower back and hamstring muscles. equipment required: sit and reach box (or alternatively a ruler can be used, and a step or box). procedure: This test involves sitting on the floor with legs stretched out straight ahead. Shoes should be removed. The soles of the feet are placed flat against the box. Both knees should be locked and pressed flat to the floor - the tester may assist by holding them down. With the palms facing downwards, and the hands on top of each other or side by side, the subject reaches forward along the measuring line as far as possible. After some practice reaches, the subject reaches out and holds that position for at least one to two seconds while the distance is recorded. Ayala et al. showed acceptable reproducibility measures for the sit and reach test with 8.74% coefficient of variation (CV) and 0.92 intraclass correlation coe

    From baseline to the end of the treatment at 6 weeks

Study Arms (3)

group 1

EXPERIMENTAL

this arm will receive muscle energy technique using the post isometric relaxation principle

Other: Muscle Energy Teqnique using post isometric relaxation (PIR) principleOther: Conventional Treatment group

group 2

EXPERIMENTAL

this group will recieve muscle energy technique using the receprocal inhibition (RI) principle

Other: Muscle Energy Teqnique using receprocal inhibition (RI) principleOther: Conventional Treatment group

group 3

ACTIVE COMPARATOR

This group will receive a 10-minute application of high-frequency TENS. Hot moist pack: The patient will be made to lie in a supine position with the affected knee in slight flexion. A hot moist pack will be applied around the knee for 15 minutes. Ankle pumps, Heel slides, Open chain knee flexion and extension exercises, Straight leg raise, Quad isometrics and Calf stretch. All these exercises were given 10 repetitions x1 set, three days/week.

Other: Conventional Treatment group

Interventions

The contralateral leg may be either flexed or may lie straight on the plinth. The affected leg will be flexed at both the hip and knee joints, and then slowly straightened by the therapist until the restriction barrier is identified. The limb will be moved a little away from the restriction barrier and the isometric contraction against resistance is introduced. The patients will be asked to resist the movement with no more than 25% of strength. The contraction will be held for 7-10 seconds followed by complete relaxation of the limb. On exhalation, the knee joint will be straightened (extended) towards its new barrier, and through that barrier a stretch will be applied and maintained for 30 seconds. 3 repetitions

group 1

The supine patient will ask to fully flex the hip and knee on the affected side. The affected leg will then be slowly straightened by the therapist until the restriction barrier is identified. The calf of the affected leg will then be placed on the practitioner's shoulder that stands facing the head of the table on the side of the affected leg. Then the patient will be asked to attempt to straighten the lower leg utilizing the antagonists to hamstrings, employing approximately 20 percent of the strength of the quadriceps. This will be resisted by the practitioner for 5 to 7 seconds. Appropriate breathing instructions will be given. On exhalation, the knee joint will be straightened (extended) towards its new barrier and through that barrier a stretch will be applied and maintained for 30 seconds. 3 repetitions)four repetition

group 2

This group will receive a 10 minutes application of high-frequency TENS. Hot moist pack: The patient will be made to lay in a supine position with the affected knee in slight flexion A hot moist pack will be applied around the knee for 15 minutes. Ankle pumps, Heel slides, Open chain knee flexion and extension exercises, Straight leg raise, Quad isometrics and Calf stretch. All these exercises were given 10 repetitions x1 set, three days/week

group 1group 2group 3

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Radiologically and clinically diagnosed cases of Osteoarthritis knee by a certified Orthopaedic surgeon or Physiotherapist. Patients with Grade 2 or 3. Osteoarthritis knee according to Kellgren - Lawrence classification,
  • Between the age group of 40-60 years, including both men and women.
  • Hamstring tightness of more than 20 from the active knee extension test (AKET)

You may not qualify if:

  • Other knee joint pathologies such as Chondromalacia patella, plica syndrome,
  • Neurological disorders.
  • Patients having lower extremity injury/surgeries in the past 6 months,
  • Hip or knee fractures or deformity,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hail

Hail, Ha'il Region, 3994, Saudi Arabia

Location

Study Officials

  • Hisham M Hussein, PhD

    University of Hail

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The participants will be assigned to the groups using permuted block design. The number of blocks will be 4 and 6. The person (not involved in assessment nor treatment) who will be responsible for allocation will give each participant a code number indicating his/her group. only the therapist will be allowed to reveal the code number interpretation to provide the appropriate intervention, while patients, the assessor, and the data analyzer (statistician) will be kept blind throughout the study. regarding the statistician, the raw data will be sent after removal of the group name, which will be replaced by a code letter.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study model will include 2 parallel groups of equal number. Each group will receive a different variation of muscle energy technique (MET)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

April 30, 2025

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

December 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

because they will be used in other future studies

Locations