The Effectiveness of Lumber Regression Technique on Disc Bulge Randomized Control Trial

NCT06548334 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/736
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar disc bulges lead to considerable pain and disability in affected individuals, with current interventions lacking consistency of outcomes. The lumbar regression method offered a hopeful, noninvasive option.

Conditions

Disc Disease

Outcome Measures

Primary Outcomes (2)

• Roland Morris disability questionnaire

  The Roland-Morris low back pain and disability questionnaire (RMD) was utilised to evaluate the quality of life prior to and following the completion of the treatment. This questionnaire has demonstrated strong validity and reliability. The score is measured on a scale of 0 to 24, and percentage scores were calculated for each participant. Greater scores indicate a greater level of disabilities. Its sensitivity is 95%, and its specificity is 69%.

  12 Months

• Straight Leg Raise

  The normal angle for an SLR is from 0-35 degrees, which signifies the least amount of strain. Stretched from 35-70 degrees, sciatic nerve root stretching is achieved, and possible problems such as herniated disc or radiculopathy may be evidenced. 70- 90 degrees reflect highest normal flexibility: it may be related to hip joint pathology or some other conditions which are not a result of nerve injury. During both the first evaluation and the final therapy, the SLR was assessed using a digital inclinometer (clinometer) installed on a Techno Camon 20 Android phone. The digital inclinometer has been found to exhibit high levels of reliability and validity

  12 months

Study Arms (2)

Advanced Physiotherapy

EXPERIMENTAL

Combination Product: Advanced Physiotherapy

Conventional Physiotherapytechniques

ACTIVE COMPARATOR

Other: Conventional Physiotherapy Techniques

Interventions

Advanced Physiotherapy COMBINATION_PRODUCT

The physiotherapist used the regression techniques for 1 hour of session 2 times for 8 weeks. The caudal component involved the spinous process of the treated segment touching the therapist's hand and not applying force as though mobilising the segment at grade 2. These were applied if there is a suspected case of a posterolateral disc prolapse where the aim is to increase the diameter of the foramen and decrease the tension exerted on the nerve root. Applied posteroanterior was used to distract the anterior intervertebral end plate and to approximate the posterior end plates so as to pull back the protruded nuclear material by creating a negative pressure.

Advanced Physiotherapy

Conventional Physiotherapy Techniques OTHER

In traditional physiotherapy, the patient underwent two sessions per week for eight weeks. Each session lasted one hour and included 20minutes of TENS treatment. The flexibility exercises consisted of hamstring stretches and single and double knee-to-chest stretches. The strengthening exercises were partial sit-ups, quadruped lifts, and double leg hold; pelvic tilts were performed with 10-15 repetitions, each held for 20-30 seconds and repeated three times.

Conventional Physiotherapytechniques

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with a diagnosis of Disc bulge confirmed by MRI.
• Between 18 and 65 years of age.
• Chronic low back pain from the last 3 months
• A stable treatment environment that allows intervention.
• Ability to understand and follow course directions.
• Willingness to give informed consent

You may not qualify if:

• Spondylolisthesis
• Spondylosis
• Vertebral fracture
• Lack of ava
• Further research interventions.
• Unstable medical condition

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Nemat Hospital & Heart Center, Manga Mandi

Lahore, Punjab Province, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: September 30, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)