NCT05475912

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 24, 2022

Last Update Submit

July 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 Day

Secondary Outcomes (1)

  • Modified oswestry disability index

    7 Day

Study Arms (2)

group A, Conventional Pysical Therapy treatment

EXPERIMENTAL

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.

Other: Group A, excercises

Group B, Talocrural joint manipulation and Conventional Physical Therapy treatment

EXPERIMENTAL

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.

Other: Group A, excercises

Interventions

Each group will receive treatment three times per week for 3 weeks total 7 sessions.

Also known as: Group B,manipulation
Group B, Talocrural joint manipulation and Conventional Physical Therapy treatmentgroup A, Conventional Pysical Therapy treatment

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kashmala Saleem

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Waqar Ahmed Awan, PhD

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 27, 2022

Study Start

March 1, 2022

Primary Completion

June 10, 2022

Study Completion

June 10, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations