NCT06407206

Brief Summary

The aim of study is to determine the effects of sub occipital muscle inhibition technique in mechanical low back pain, hamstring muscle flexibility, lumbar ranges and functional disability. This study will focus on either this technique have effects on reliving lumbar pain, improving flexibility of hamstring muscles and lumbar ranges or not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

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

Study Start

First participant enrolled

April 1, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

April 29, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

mechanical low back painsub occipital muscle inhibitionhamstring flexibility

Outcome Measures

Primary Outcomes (4)

  • Active knee extension test:

    Active knee extension test is performed for assessing the flexibility of hamstring muscles. The test is performed by positioning the participant in supine position, hip is placed at 90 degrees of flexion while opposite leg is stabilized in order to avoid hip flexion. The lumbar spine is in neutral position. The fulcrum of goniometer is placed over the lateral condyle of femur, proximal arm of goniometer is placed on the lateral surface of femur keeping the greater trochanter for reference and the distal arm is placed along the lateral surface of fibula with lateral malleolus keeping for reference. The participant is then asked to actively extend the knee till the point of pain or maximum tolerable stretch to hamstring muscle, measurements are then recorded from goniometer. its reliability with intra-class correlation coefficient (ICC) of 0.87 for dominant knee and 0.81 for non-dominant knee. .

    two weeks

  • Numeric Pain Rating Scale (NPRS):

    The Numeric Pain Rating Scale (NPRS) is used to measure the subjective intensity of pain. The NPRS is an eleven-point scale ranging from 0 to 10. In which "0" is for no pain and "10" is for the most intense/worst pain, while the NPRS exhibited moderate reliability (ICC = 0.27-0.84)

    two weeks

  • Inclinometer for range of motion

    An inclinometer is a commonly used device in physiotherapy to measure angles and the range of motion (ROM) of joints.it consists of a sensor which is sensitive to gravity and measures the angles, angle is then displayed on a digital display or a dial. The angle of the inclinometer will change as the joint moves. The maximum angle reached is the ROM of the joint. Inter-rater reliability of inclinometer is ICCs 0.71-0.87.

    two weeks

  • Oswestry disability index questionnaire (ODI):

    The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researcher use to measure a patient\'s permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Questionnaire examines the level of disability in 10 everyday activities of daily living which includes pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social interaction, travel, employment/ homemaking. Each item consists of 6 statements which are scored from 0-5, 0 indicating least disability and 5 indicates the greatest, total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability. Test-retest reliability was consistently high across studies (mean ICC value of 0.937 ± 0.032).

    two weeks

Study Arms (2)

Sub occipital muscle inhibition technique along with conventional therapy

EXPERIMENTAL

Patient is in supine position Therapist sits near the head of the participant and places his hand below the head of the participant With the pads of hand therapist palpates the arch of atlas between the occipital protuberance and spinous process of axis and place the middle and ring finger over it by flexing the metacarpophalangeal joint in 90 degrees of flexion, base of skull will rest on hands Pressure is exerted in upward direction towards the therapist and is maintained for two minutes so that the muscle scan relax Participants are guided to keep their eyes close in order to avoid movement which affects the tone of sub occipital muscle

Other: Sub occipital muscle inhibition technique and conventional therapy

conventional therapy

OTHER

Transcutaneous electrical nerve stimulation at lower back and hamstring muscles (pulse rate: 4Hertz, pulse duration: 150µs for 15mins) Hot pack ( 15mins),Ankle pumps (15 reps with 5 sec hold), Knee Range of motions (flexion and extension,10 reps),Quadriceps set (10 reps,5 sec hold),Vastus Medialis oblique (10 reps 5 sec hold),Gluteus sets (10 reps, 5 sec hold),Single knee to chest (10 reps with 10 sec hold) McKenzie exercises (10 reps with 10 sec hold and 10 sec rest),Stretching of calf and hamstring muscles (passive stretching,7 reps with 5 sec hold).

Other: conventional therapy

Interventions

Patient is in supine position Therapist sits near the head of the participant and places his hand below the head of the participant With the pads of hand therapist palpates the arch of atlas between the occipital protuberance and spinous process of axis and place the middle and ring finger over it by flexing the metacarpophalangeal joint in 90 degrees of flexion, base of skull will rest on hands Pressure is exerted in upward direction towards the therapist and is maintained for two minutes so that the muscle scan relax Participants are guided to keep their eyes close in order to avoid movement which affects the tone of sub occipital muscle

Sub occipital muscle inhibition technique along with conventional therapy

Transcutaneous electrical nerve stimulation at lower back and hamstring muscles (pulse rate: 4Hertz, pulse duration: 150µs for 15mins) Hot pack ( 15mins),Ankle pumps (15 reps with 5 sec hold), Knee Range of motions (flexion and extension,10 reps),Quadriceps set (10 reps,5 sec hold),Vastus Medialis oblique (10 reps 5 sec hold),Gluteus sets (10 reps, 5 sec hold),Single knee to chest (10 reps with 10 sec hold) McKenzie exercises (10 reps with 10 sec hold and 10 sec rest),Stretching of calf and hamstring muscles (passive stretching,7 reps with 5 sec hold).

conventional therapy

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic mechanical low back pain \> 12 weeks
  • Patients with hamstring tightness having popliteal angle more than 30 degrees.
  • Negative sacroiliac distraction test to exclude sacroiliac joint pain

You may not qualify if:

  • Acute severe low back pain
  • Patients with hamstring injury
  • Active tumor or infection
  • Fractures of cervical and lumbar spine
  • History of previous lumbar, hip and knee surgery
  • Migraine
  • Fever
  • Sacroiliac joint dysfunction
  • Cauda equine syndrome
  • Patients having cognitive or mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ali Therapy clinic

Islamabad, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 9, 2024

Study Start

April 1, 2024

Primary Completion

June 10, 2024

Study Completion

July 1, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations