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Clinical Trials/CTRI/2024/11/076731
CTRI/2024/11/076731
Not yet recruiting
Phase 3

To find the Effectiveness of Core Stabilization Exercises along with Conventional Physiotherapy versus Kinesio Taping along with Conventional Physiotherapy on Pain Function and Quality of Life in Patients with Non-Specific Low Back Pain: A Comparative Study

Raina Mishra1 site in 1 country40 target enrollmentStarted: November 23, 2024Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Raina Mishra
Enrollment
40
Locations
1
Primary Endpoint
Pain by using the NPRS scale Roland Morris Questionnaire for Function

Overview

Brief Summary

40 participants will be randomly divided into two groups. In Group A: all 20 patients will be treated by Core Stabilization along with conventional physiotherapy treatment. Group B: all 20 patients will be treated with Kinesio taping along with conventional physiotherapy treatment. All participants will be assessed for back pain, function, and Quality of life. A Numeric Pain Rating Scale (NPRS) will be used to measure the intensity of pain, functional performance will be assessed using the Roland Morris Disability Questionnaire (RMDQ) scale, and Quality of life will be assessed by SF -36.

All variables will be measured at baseline, at the end of the second week and third week of the study.

Group A (Core Stabilization exercises along with conventional physiotherapy)

Warm-up Includes a combination of dynamic stretching and light aerobic activities to increase blood flow and prepare the muscles for exercise.

Core Activation Exercises:

a. Pelvic Tilts: Lie on your back with knees bent. Gently tilt your pelvis upward, flattening your lower back against the floor. Hold for a few seconds and release. Repeat 10  times.

b. Bridging: Lie on your back with knees bent and feet hip-width apart. Lift your hips toward the ceiling, engaging your glutes. Hold for a few seconds and lower back down. Repeat 10 times.

Core Strengthening Exercises:

a. Plank: Start in a forearm plank position. Maintain a straight line from head to heels, engaging the core. Hold for 20-30 seconds, gradually increasing the duration.

b. Dead Bug: Lie on your back with arms extended toward the ceiling and legs lifted. Lower one arm and the opposite leg toward the ground without arching your back. Return to the starting position and repeat on the other side. Perform 10  reps.

Flexibility and Mobility Exercises:

a. Cat-Cow Stretch: Start on hands and knees. Arch your back up (cat) and then lower it down (cow) in a controlled manner. Repeat for 10 cycles.

b. Child’s Pose: Kneel on the floor, sit back on your heels, and reach your arms forward. Hold for 20-30 seconds, feeling a stretch in the lower back.

10 repetitions were given per session with 30 secs of rest will be given in between the session. Total 5 sessions in a week for 3 weeks

Conventional Physiotherapy

Soft Tissue Mobilization: Method: Hands-on techniques to address muscle tightness and trigger points.

Myofascial Release (Foam Rolling): Roll the foam roller along the muscles of the lower back, paying attention to areas of tightness. Focus on the paraspinal muscles, glutes, and hip rotators.

Trigger Point Release: Use a massage ball or your fingers to apply pressure to specific trigger points in the lower back and surrounding areas.29

Education and Ergonomics: Provide education on posture, body mechanics, and ergonomics to promote optimal spine health.

10 repetitions were given per session with 30 secs of rest will be given in between the session. Total 5 sessions in a week for 3 weeks

Modality: Electrotherapy Interferential Current (IFT):

Interferential Current will be given on the painful area for 5 days a week for an initial 3 weeks according to the protocol mentioned below

Interferential current for pain relief. A patient will be advised to do the exercises in 5 sessions per week.

 Group B (K-Taping along with conventional Physiotherapy)

Patient position: Usually in a comfortable, neutral position – either lying down or sitting. Skin Preparation: Ensure the skin is clean and dry before applying the tape. For Lumbar Spine Support: Apply a Y-strip or I-strip vertically along the spine, covering the lumbar region. The tape may provide support and proprioceptive feedback,  For Painful Areas: Apply additional strips or fan strips around the area of pain, extending from the spine to the sides. This may help in reducing local discomfort, Direction of Pull: The direction of the tape’s pull may vary based on the intended effect – it could be applied with stretch or without, depending on the therapeutic goal.

Taping Technique: Y-Strip: This involves applying a single strip of tape with two tails extending from a common base. It is commonly used for spine support, I-Strip: A single strip without tails, often used for general support or to follow muscle fibers. The duration of the K-tape application can vary. Some practitioners recommend wearing the tape for 3-5 days, allowing for skin breathing periods.

In Conventional physiotherapy, subjects receive physiotherapy exercises and physical modalities such as Interferential Current (IFT).

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diagnosed with nonspecific low back pain based on clinical evaluation, and a history of LBP exceeding 12 weeks.
  • Able to understand and follow exercise or taping instructions.
  • Have a minimum pain level (at activity) of 2 or above on NPRS (Numeric Pain Rating Scale) and had LBP for at least 3 months Willing to participate in a supervised rehabilitation program.

Exclusion Criteria

  • Individuals with specific pathologies causing low back pain (e.g., herniated disc, spinal stenosis).
  • History of spine surgery within the past year.
  • Known allergy or skin sensitivity to taping materials.
  • Pregnancy, as core stabilization exercises, may need modification.
  • Cardiovascular or systemic diseases or any condition which contraindicated or made exercise training impossible.
  • Physiotherapy previously received for at least 12 months or any surgery affecting the lumbar region.

Outcomes

Primary Outcomes

Pain by using the NPRS scale Roland Morris Questionnaire for Function

Time Frame: 3 weeks

Quality of life by using SF-36 score Instrument

Time Frame: 3 weeks

Secondary Outcomes

  • Pain by using the NPRS scale Roland Morris Questionnaire for Function(Quality of life by using SF-36 score Instrument)

Investigators

Sponsor
Raina Mishra
Sponsor Class
Other [(self)]
Responsible Party
Principal Investigator
Principal Investigator

Raina Mishra

Mahatma Gandhi University of Medical Sciences and Technology

Study Sites (1)

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