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Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain

Primary Purpose

Mechanical Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group A, excercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Low Back Pain

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants falling in this category would be recruited into the study.

    • Willingness of participant.
    • Age group between 21-45 years (both male and female).
    • Localized, Low back pain- Sub acute(6-12 weeks) and chronic low back pain(12 weeks and above)
    • Asymptomatic Ankle- Pronated foot, Flat foot, Healed ankle injuries.
    • Test for inclusion of foot: Feiss line test (Medial Longitudinal Arch Angle), Stress Test for Ankle ligaments (Anterior Drawer Test, Talar Tilt Test, Eversion Stress Test).

Exclusion Criteria:

  • Participant failing to fall in this category would be excluded of the study.

    • Any recent injury of spine or lower limb.
    • Any unhealed ankle injuries.
    • Patients with neurological deficit such as paresthesia, numbness and weakness in lower limb.
    • Spondylolysis or any defect or stress fracture in the pars interarticularis of the vertebral arch.
    • Spondylolisthesis or any displacement of vertebra.
    • Spinal fracture or any trauma in spinal column.
    • Spinal tumors (both primary and metastatic tumor).
    • Spinal surgery such as lumbar decompression surgery, lumbar fusion surgery.
    • Artificial disc replacement surgery.
    • Pregnancy.
    • Disc prolapsed such as protrusion, prolapse, extrusion and sequestration.
    • Any spinal curvature defect.
    • Receiving steroid injection within previous 3 months.
    • History of systemic disorder and malignancy.
    • Diagnosed diabetic patients.
    • Diagnosed Osteoporotic patients

Sites / Locations

  • Kashmala Saleem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group A, Conventional Pysical Therapy treatment

Group B, Talocrural joint manipulation and Conventional Physical Therapy treatment

Arm Description

group A will be given, Electrotherapy Modalities treatment:Hot pack - 20 min,Transcutaneous Electrical Nerve Stimulator - 30 min and will perfome Active Exercises including;Knee to chest exercise,Hamstring stretch, Pelvic bridging,Pelvic tilt, Lumbar rotation stretch exercise.(1set with10 reps of each excercise) Home exercise plan & precautions; Perform above mentioned active exercises, 3 sessions per day (1sets x 10 reps) will also be given to Group A.

group Bwill be given, Talocrural Joint Manipulation with Electrotherapy Modalities treatment:Hot pack - 20 min,Transcutaneous Electrical Nerve Stimulator - 30 min and will perfome Active Exercises including;Knee to chest exercise,Hamstring stretch, Pelvic bridging,Pelvic tilt, Lumbar rotation stretch exercise.(1set with10 reps of each excercise) Home exercise plan & precautions; Perform above mentioned active exercises, 3 sessions per day (1sets x 10 reps) will also be given to Group B.

Outcomes

Primary Outcome Measures

Visual analogue scale
Effects of Talo-crural joint Thrust Manipulation along with Conventional Physiotherapy Treatment will be observed on Mechanical Low Back Pain, through visual analogue scale. Findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. assesment will be made on baseline, before intervention, on 4th session after intervention and on 7th session after intervention.

Secondary Outcome Measures

Modified oswestry disability index
Effects of Talo-crural joint Thrust Manipulation along with Conventional Physiotherapy Treatment will be observed on quality of life among mechanical low back pain patients, through modified oswestry disability index. ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum) Assesment will be made on baseline, before intervention, on 4th session after intervention and on 7th session after intervention.

Full Information

First Posted
July 24, 2022
Last Updated
July 24, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05475912
Brief Title
Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain
Official Title
Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
June 10, 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
No

5. Study Description

Brief Summary
Among all disabling musculoskeletal condition, non specific low back pain is most prevalent and universal condition. Its prevalence has increased over years and affects almost all at some phase in their life. Though, there are many causes of low back pain such as, sedentary life style, depression, poor nutritionist diet and so on, yet faulty posture is also one of the noteworthy causes of low back pain which cannot be overlooked. Faulty posture can result from any out of order body component, such as atypical foot biomechanics. Since lower limb is connected in a closed chain, atypical foot biomechanics leads to disruption in the whole chain ascending up to the spine, stressing spine soft tissues, upsetting its normal anatomical position and causing low back pain.
Detailed Description
The lower limb is made up of all the structures from feet to pelvic, forming a closed mechanical chain. In this chain if any one segment is out of its neutral position it affects the whole chain. Like, if a foot is out of its alignment can be flattened or highly pronated, it will results in ankle internal rotation i,e. during the early stance phase of gait When the foot pronates, the calcaneus everts while the talus adducts and the plantar flexes. This inferomedial translation of the talus, results in inward rotation of shin and knee. Knee internal rotation, then make femur to rotate medially (internally) and pelvic to tilt anteriorly. This increased tilting of pelvic increases the curvature of the lumbar spine. Excessive curve at lumbar spine places excessive strain on the muscles, tendons and ligaments of the lower back, causing them to inflame and resulting pain. This domino effect, explains how a misalignment in the foot end up negatively effecting the health of one's lower back and a source of non specific low back pain.Though the direct treatment of lumbar region is important for LBP,yet ankle strategy is needed in order to correct the spinal imbalance. This research proceeded with the thought of taking a whole approach i.e. treating the main cause, causing LBP rather than just applying specific approach i.e. giving only symptomatic treatment for pain alleviation. With this approch talocrural/ankle joint is being taken within physical therapy treatment sphere through manipulation technique along with conventional physical therapy protocol for LBP in the current study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A, Conventional Pysical Therapy treatment
Arm Type
Experimental
Arm Description
group A will be given, Electrotherapy Modalities treatment:Hot pack - 20 min,Transcutaneous Electrical Nerve Stimulator - 30 min and will perfome Active Exercises including;Knee to chest exercise,Hamstring stretch, Pelvic bridging,Pelvic tilt, Lumbar rotation stretch exercise.(1set with10 reps of each excercise) Home exercise plan & precautions; Perform above mentioned active exercises, 3 sessions per day (1sets x 10 reps) will also be given to Group A.
Arm Title
Group B, Talocrural joint manipulation and Conventional Physical Therapy treatment
Arm Type
Experimental
Arm Description
group Bwill be given, Talocrural Joint Manipulation with Electrotherapy Modalities treatment:Hot pack - 20 min,Transcutaneous Electrical Nerve Stimulator - 30 min and will perfome Active Exercises including;Knee to chest exercise,Hamstring stretch, Pelvic bridging,Pelvic tilt, Lumbar rotation stretch exercise.(1set with10 reps of each excercise) Home exercise plan & precautions; Perform above mentioned active exercises, 3 sessions per day (1sets x 10 reps) will also be given to Group B.
Intervention Type
Other
Intervention Name(s)
Group A, excercises
Other Intervention Name(s)
Group B,manipulation
Intervention Description
Each group will receive treatment three times per week for 3 weeks total 7 sessions.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
Effects of Talo-crural joint Thrust Manipulation along with Conventional Physiotherapy Treatment will be observed on Mechanical Low Back Pain, through visual analogue scale. Findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. assesment will be made on baseline, before intervention, on 4th session after intervention and on 7th session after intervention.
Time Frame
7 Day
Secondary Outcome Measure Information:
Title
Modified oswestry disability index
Description
Effects of Talo-crural joint Thrust Manipulation along with Conventional Physiotherapy Treatment will be observed on quality of life among mechanical low back pain patients, through modified oswestry disability index. ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum) Assesment will be made on baseline, before intervention, on 4th session after intervention and on 7th session after intervention.
Time Frame
7 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants falling in this category would be recruited into the study. Willingness of participant. Age group between 21-45 years (both male and female). Localized, Low back pain- Sub acute(6-12 weeks) and chronic low back pain(12 weeks and above) Asymptomatic Ankle- Pronated foot, Flat foot, Healed ankle injuries. Test for inclusion of foot: Feiss line test (Medial Longitudinal Arch Angle), Stress Test for Ankle ligaments (Anterior Drawer Test, Talar Tilt Test, Eversion Stress Test). Exclusion Criteria: Participant failing to fall in this category would be excluded of the study. Any recent injury of spine or lower limb. Any unhealed ankle injuries. Patients with neurological deficit such as paresthesia, numbness and weakness in lower limb. Spondylolysis or any defect or stress fracture in the pars interarticularis of the vertebral arch. Spondylolisthesis or any displacement of vertebra. Spinal fracture or any trauma in spinal column. Spinal tumors (both primary and metastatic tumor). Spinal surgery such as lumbar decompression surgery, lumbar fusion surgery. Artificial disc replacement surgery. Pregnancy. Disc prolapsed such as protrusion, prolapse, extrusion and sequestration. Any spinal curvature defect. Receiving steroid injection within previous 3 months. History of systemic disorder and malignancy. Diagnosed diabetic patients. Diagnosed Osteoporotic patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waqar Ahmed Awan, PhD
Organizational Affiliation
Riphah International University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kashmala Saleem
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

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Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain

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