Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients

NCT05649774 | Completed DMC

• 1 other identifier: KArshad
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Lower back pain has been one of the most frequently occurring musculoskeletal disorder among the females. This act as a global burden and is highly prevalent in our society. This pain can result in life long disability, loss of function and mobility among individuals. The female of the society suffers from lower back pain the most because of the under lying causes, prolong standing and stooping as well as because of hormonal changes in their bodies

Conditions

Lower Back Pain; Musculoskeletal Diseases or Conditions

Keywords

Lower back pain; Non specific lower back pain

Outcome Measures

Primary Outcomes (2)

• Lower Back Pain

  Numeric Pain Rating Scale

  Change from baseline to week 3

• Disability of lower back

  Oswestry Disability Index

  Change from baseline to week 3

Secondary Outcomes (4)

• Range of Motion

  Change from baseline to week 3

• Pain Pressure Threshold

  Change from baseline to week 3

• Tissue Hardness

  Change from baseline to week 3

• Quality of Life of patients with Lower back pain

  Change from baseline to week 3

Study Arms (4)

Myofascial Release (MFR)

ACTIVE COMPARATOR

The therapist will place its hands on the T12-L1 levels as well as on the sacrum. A cross handed hold will be performed along the fascia. Then for the gluteus Medius and maximus muscle, the therapist will stand facing the participant's leg and closed to the superior border of participant's pelvis. The therapist will place the palm of the hand on the anterior surface, allowing the fingers to rest on the outer fibers of the gluteal muscles stabilizing the pelvis of the participants. Allow the participant to flex its knee while applying adequate amount of stretch on the hip joint in an open pack position. Hold, wait for the release and stretch again. for tensor fascia Latae, The therapist will place several slightly adducted fingers of its one hand on the superior fibers proximal to the insertion on the anterior superior iliac crest and the thumb as well as the other fingers of the other hand on the distal muscle fibers. Hold, wait for the release and stretch again.

Procedure: Therapy

Kinesio Taping (KT)

ACTIVE COMPARATOR

Lumbar star correction technique was applied. 4 tape I strips will be cut. The paper from the center will be torn. The targeted area will be stretched as tolerated at the lumbar region. The therapist will apply 25% to 35% tension to the strip within the therapeutic zone over the target tissue. End the strip with no tension and activate the adhesive. For the second strip change the posture in order to change the stretch on the tissue, apply the second strip with 25% to 35% tension in the center of the tape and end with no tension. Activate the adhesive. Now flex the trunk and rotate on one side. Apply the third tape strip with 25% to 35% tension in the center of the tape. Apply the fourth tape strip with flexion and rotation on the opposite side again with 25% to 35% tension on the strip. The tape will be changed 3 times per week.

Procedure: Taping technique

Myofascial Release with Taping (MFKT)

EXPERIMENTAL

Same Protocol of MFR followed by KT

Procedure: Therapy with taping

Placebo Treatment

SHAM COMPARATOR

The control group received a sham myofascial release for 40 minutes per treatment session, three times a week for three weeks. The sham myofascial release was applied by gently placing the hands over the same areas treated in the MFR group,without sliding, just enough to maintain contact for the desired time.

Procedure: SHAM

Interventions

Therapy PROCEDURE

Only Myofascial Release will be provided

Also known as: Myofascial Release

Myofascial Release (MFR)

Taping technique PROCEDURE

Only Kinesiotaping will be provided

Also known as: Taping

Kinesio Taping (KT)

Therapy with taping PROCEDURE

Myofascial release will be provided followed by Kinesiotaping

Also known as: Therapy followed by taping

Myofascial Release with Taping (MFKT)

SHAM PROCEDURE

Placebo Treatment will be given

Placebo Treatment

Eligibility Criteria

• Age: 28 Years - 38 Years
• Gender Eligibility Details: Only females will be included in the study because lower back pain is highly prevalent among them.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females who were willing to participate.
• Participants with nonspecific lower back pain will only be included and screened through the screening questionnaire.

You may not qualify if:

• Post-menopausal women
• Females with any diagnosed co-morbidity.
• Back pain progressive to any neurological deficit
• Sustained or increased back pain with loss of appetite and unexplained weight loss accompanied with fever, nausea and chills
• With any known spinal or lower back pathology
• Tumor of the spine
• Any underlying diseases of spinal cord (i.e, ankylosing spondylosis, spondolisthesis)
• With any steroid therapy for lower back pain in the past three months
• Any inflammatory rheumatic disease
• Sensitive skin or any skin allergy or dermatological condition
• Any rehabilitative services taken for the lower back pain in the past two months
• Rejection to manual conatct

Sponsors & Collaborators

• University of Karachi: lead

Study Sites (1)

Al-Tibri Medical college and hospital

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain; Musculoskeletal Diseases

Interventions

Therapeutics; Myofascial Release Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kiran Arshad, M.Phil

  University of Karachi

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study was a parallel group, four arm superiority trial with 1:1 allocation ratio and balanced randomization

Study Record Dates

• First Submitted: November 19, 2022
• First Posted: December 14, 2022
• Study Start: December 14, 2022
• Primary Completion: January 20, 2023
• Study Completion: January 25, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)