Lumbosacral Disc SyndromeNCT07068321
Effects Of GDS Method Along With CBTThrough Smartphone Health App For Patients With Chronic LDP
A study testing Godelieve Denis-Struf and Godelieve Denis-Struf + Cognitive Behavioral Therapy in people with Lumbosacral Disc Syndrome, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Lumbosacral Disc Syndrome
- What is being tested?
- Godelieve Denis-Struf and Godelieve Denis-Struf + Cognitive Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Apr 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 40 to 65 years
- Diagnosed chronic lumbosacral discogenic pain by a physician or neuro-physician.
- No surgical history of lumbosacral area
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Godelieve Denis-Struf (GDS) Method Along With Cognitive Behavioral Therapy Through Smartphone Health App For Patients With Chronic Lumbosacral Discogenic Pain.
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.
Read the detailed description
The Godelieve Denis-Struf (GDS) method has been shown to improve posture, mobility, and muscular imbalances in patients with musculoskeletal pain. Cognitive Behavioral Therapy (CBT) is another effective intervention that addresses the psychological factors contributing to chronic pain. With the rise of digital health solutions, smartphone applications have emerged as convenient tools to deliver these therapeutic methods. This study explores the combined effects of GDS exercises and CBT via a smartphone health app for individuals suffering from chronic lumbosacral discogenic pain.
- Conditions
- Lumbosacral Disc Syndrome
- Being tested
- Control Group (transcutaneous electrical nerve stimulation), Godelieve Denis-Struf, Godelieve Denis-Struf + Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Godelieve Denis-StrufCombination 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 + Cognitive Behavioral TherapyCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (transcutaneous electrical nerve stimulation) | Experimental | Not described Receives: Combination Product: Control Group (transcutaneous electrical nerve stimulation) |
| Godelieve Denis-Struf | Active comparator | Not described Receives: Combination Product: Godelieve Denis-Struf |
| Godelieve Denis-Struf + Cognitive Behavioral Therapy | Active comparator | Not described Receives: Combination Product: Godelieve Denis-Struf + Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start17 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral Disc SyndromeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068321
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2221
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Godelieve Denis-Struf (GDS) Method Along With Cognitive Behavioral Therapy Through Smartphone Health App For Patients With Chronic Lumbosacral Discogenic Pain.
- ClinicalTrials.gov ID
- NCT07068321
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2221
- Conditions
- Lumbosacral Disc Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Godelieve Denis-Struf (GDS) method has been shown to improve posture, mobility, and muscular imbalances in patients with musculoskeletal pain. Cognitive Behavioral Therapy (CBT) is another effective intervention that addresses the psychological factors contributing to chronic pain. With the rise of digital health solutions, smartphone applications have emerged as convenient tools to deliver these therapeutic methods. This study explores the combined effects of GDS exercises and CBT via a smartphone health app for individuals suffering from chronic lumbosacral discogenic pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 40 to 65 years
- Diagnosed chronic lumbosacral discogenic pain by a physician or neuro-physician.
- No surgical history of lumbosacral area
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Group (transcutaneous electrical nerve stimulation)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. | Combination product | Control Group (transcutaneous electrical nerve stimulation) |
| Godelieve Denis-StrufExperimental 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. | Combination product | Godelieve Denis-Struf |
| Godelieve Denis-Struf + Cognitive Behavioral TherapyExperimental 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. | Combination product | Godelieve Denis-Struf + Cognitive Behavioral Therapy |
Primary outcome
The Oswestry Disability Index (ODI)
Time frame: 18 Months
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
SF-36 (Short Form 36)
Time frame: 18 Months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Godelieve Denis-Struf and Godelieve Denis-Struf + Cognitive Behavioral Therapy in people with Lumbosacral Disc Syndrome, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Oswestry Disability Index (ODI) (time frame: 18 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.