Effects Of GDS Method Along With CBTThrough Smartphone Health App For Patients With Chronic LDP

NCT07068321 | Active Not Recruiting DMC

• 1 other identifier: PhDRSW/Batch-Fall23/2221
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic lumbosacral discogenic pain is a common and debilitating condition that significantly affects the quality of life of patients. Traditional treatments often focus on pain management, but a holistic approach combining physical exercises and psychological therapy can offer more sustainable relief.

Conditions

Lumbosacral Disc Syndrome

Outcome Measures

Primary Outcomes (2)

• The Oswestry Disability Index (ODI)

  The Oswestry Disability Index (ODI) is a questionnaire used to assess the impact of low back pain on a person's daily life. It consists of 10 sections, each with six statements, and patients select the statement that best describes their situation. Each section is scored from 0 to 5, with 0 indicating no disability and 5 indicating the worst imaginable disability. The total score is then calculated and can be expressed as a percentage, with a higher score indicating greater disability

  18 Months

• SF-36 (Short Form 36)

  The SF-36 (Short Form 36) is a questionnaire used to assess health-related quality of life, encompassing both physical and mental well-being. It consists of 36 items that evaluate eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better health

  18 Months

Study Arms (3)

Control Group (transcutaneous electrical nerve stimulation)

EXPERIMENTAL

Combination Product: Control Group (transcutaneous electrical nerve stimulation)

Godelieve Denis-Struf

ACTIVE COMPARATOR

Combination Product: Godelieve Denis-Struf

Godelieve Denis-Struf + Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Combination Product: Godelieve Denis-Struf + Cognitive Behavioral Therapy

Interventions

Control Group (transcutaneous electrical nerve stimulation) COMBINATION_PRODUCT

Control Group will consist of 20 sessions of 30 min, applied twice per week over a period of 3 months including transcutaneous electrical nerve stimulation, and standardized exercises for LBP through smart phone application.

Control Group (transcutaneous electrical nerve stimulation)

Godelieve Denis-Struf COMBINATION_PRODUCT

Experimental Group will receive 20 sessions of 30 min applied twice per week over a period of 3 months of GDS treatment through smart phone application.

Godelieve Denis-Struf

Godelieve Denis-Struf + Cognitive Behavioral Therapy COMBINATION_PRODUCT

Experimental Group 2 will receive 20 sessions of 45 min applied twice per week over a period of 3 months of GDS along CBT treatment through smart phone application.

Godelieve Denis-Struf + Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 40 to 65 years
• Diagnosed chronic lumbosacral discogenic pain by a physician or neuro-physician.
• No surgical history of lumbosacral area

You may not qualify if:

• Pregnancy
• Diagnosis of cancer
• Fibromyalgia or inflammatory disease (eg, rheumatoid arthritis or spondylitis)
• Surgical cases of lumbosacral area
• comorbidity like uncontrolled diabetes and blood pressure

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Rehabilitation Centers in Punjab

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Control Groups; Transcutaneous Electric Nerve Stimulation; Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

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: July 7, 2025
• First Posted: July 16, 2025
• Study Start: April 17, 2025
• Primary Completion: December 1, 2025
• Study Completion: June 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)