Low Back PainTELELOMBNCT05390762
Telecare Rehabilitation Program in Chronic Low Back Pain with Psychological Retention and Predominant Sociability
A study testing Common phase, Telecare rehabilitation and Care in Face to Face in people with Low Back Pain, run by Pôle Saint Hélier at 1 site in France.
Trial summary
The present study proposes to evaluate the impact of a multidisciplinary biopsychosocial Telecare rehabilitation program at the functional level in people with chronic low back pain with major psycho-behavior maintenance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Common phase, Telecare rehabilitation and Care in Face to Face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2022to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic low back pain (evolution of more than 3 months)
- Patient treated for this pathology in a multidisciplinary program
- Dallas score > 50% in anxiety/depression and sociability dimensions
- Patient who has given free and informed consent to participate in the research
- Patient affiliated to a social security scheme or beneficiary of such a scheme.
- Patient with an internet connection at home, allowing videoconferencing and a digital tool with web cam (tablet or computer).
Who cannot join
- Recent spine surgery (< 3 months at inclusion visit)
- Cardiovascular risk factor contraindicating sports practice.
- Severe psychiatric pathology
- Low back pain of tumoral or inflammatory origin.
- Associated motor or sensory, neurological impairment.
- Disabling root irradiation
- Pregnant or breastfeeding women
- Patients under legal protection (guardianship, curators or safeguard of justice).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Functional Efficacy of a Multidisciplinary Telecare Rehabilitation Program in Chronic Low Back Pain with Psychological Retention and Predominant Sociability : Single Center Randomized Controlled, Single-blind Trial
The present study proposes to evaluate the impact of a multidisciplinary biopsychosocial Telecare rehabilitation program at the functional level in people with chronic low back pain with major psycho-behavior maintenance. The hypothesis is that a personalized program combining remote psycho-professional and physical care by digital tools improves functional evaluation in these patients.
- Conditions
- Low Back Pain
- Being tested
- Common phase, Telecare rehabilitation, Care in Face to Face
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common phaseOther
A common face to face day hospital combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
Telecare rehabilitationOther
A Second phase of 5 weeks of telecare rehabilitation of the reconditioning type of 15 sessions.
Care in Face to FaceOther
A Second phase of 5 weeks of care in face to face day hospital of the reconditioning type of 15 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Conventional care in a day hospital | Active comparator | 1. A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
2. A Second phase of 5 weeks of care face to face day hospital of the reconditioning type of 15 sessions. Receives: Other: Common phase; Other: Care in Face to Face |
| Telecare rehabilitation | Experimental | 1. A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia.
2. A Second phase of 5 weeks of Telecare rehabilitation of the reconditioning type of 15 sessions. Receives: Other: Common phase; Other: Telecare rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Overall score of the Oswestry self-questionnaire. The score goes from 0 to 50, It will be converted into a percentage (Score ODI). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: 3 months after the end of rehabilitation
Secondary outcomes (14)
Economic efficiency
The economic efficiency of personalized rehabilitation at the end of the rehabilitation measured by the cost of transport evaluated according to the functional evolution by Oswestry.
Measured: At the end of the rehabilitation
Spontaneous pain
The spontaneous pain measured by Visual Analogic Scale, from 0 to 100. The 0 represents no pain at all and 100 the worth pain imaginable.
Measured: At the end of the rehabilitation and 3 month after.
Overall flexibility
Measured finger ground distance in centimeters. The patient is asked to touch the ground with both hands while standing with the knees in extension. The distance between the fingertip and the ground is recorded. Higher the distance is, the better it is.
Measured: At the end of the rehabilitation and 3 month after.
Range of motion of lumbar mobility
Active range of motion of lumbar flexion and lumbar extension will be measured with two inclinometers. Higher the score is, the better it is.
Measured: At the end of the rehabilitation and 3 month after.
Sub pelvis muscle flexibility.
The sub pelvis muscle flexibility will be measured by goniometry and centimetry. Higher the score is, the better it is.
Measured: At the end of the rehabilitation and 3 month after.
Quadriceps strength
Testing will be done 90 degrees of knee flexion using a wall. The maximum holding time will be determined with a chronometer (in seconds). Higher the score is, the better it is.
Measured: At the end of the rehabilitation and 3 month after.
Endurance of trunk extensors
Measured by the Sorensen-Biering Test (duration in seconds), higher the score is, the better it is.
Measured: At the end of the rehabilitation and 3 month after.
Endurance of trunk flexors
Measured by the Shirado test (duration in seconds), higher the score is, the better it is.
Measured: At the end of the rehabilitation and 3 month after.
Anxiety and depression
The Anxiety and depression are assessed by the self administered Hospital Anxiety and Depression scale (HAD). It has 14 items from 0 to 3. 7 questions concern, depression and 7 anxiety. The total for each scale is 21. If the score is less than 7, there in no symptomatology.
Measured: At the end of the rehabilitation and 3 month after.
The kinesiophobia
Assessment of the kinesiophobia index by the TAMPA questionnaire. There are 17 questions, from 1 to 4. If the score is high (more than 40 on 68), the kinesiophobia is significant.
Measured: At the end of the rehabilitation and 3 month after.
Functional abilities
Evaluation of the functional disability with the dallas pain questionnaire. It's divided in 4 parts : impact on daily activities, impact on the relation between professional activities and leisure, impact on the relation between anxiety and depression and the impact on sociability. The Dallas questionnaire evaluated the impact of pain from 0 (no impact) to 100% (maximum impact).
Measured: At the end of the rehabilitation and 3 month after.
Socio professional criteria
The rate of patients having resumed a professional activity and condition of resumption (part-time therapeutic or not, previous position or adapted position).
Measured: 3 months after the end of rehabilitation
Compliance
Self-assessment compliance evaluated by an adherence booklet
Measured: At the end of the rehabilitation
Acceptability
The acceptability will be assessed using a 18-item questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) model. Each questions are based on a Likert-type 5 point scale ranging from : 1=In total disagreement, 2= Somewhat disagree, 3= Neither agree nor disagree, 4= Somewhat agree, 5=In total agreement.
Measured: At the end of the rehabilitation program and 3 months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start3 May 2022
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jephté Houedakor, Principal investigator, Pôle Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390762
- Sponsor's protocol ID
- 2022-A00129-34
- Acronym
- TELELOMB
- Status last verified
- Dec 2024
- First submitted
- 6 May 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Functional Efficacy of a Multidisciplinary Telecare Rehabilitation Program in Chronic Low Back Pain with Psychological Retention and Predominant Sociability : Single Center Randomized Controlled, Single-blind Trial
- ClinicalTrials.gov ID
- NCT05390762
- Acronym / sponsor ID
- TELELOMB / 2022-A00129-34
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 25 May 2022 (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.
The present study proposes to evaluate the impact of a multidisciplinary biopsychosocial Telecare rehabilitation program at the functional level in people with chronic low back pain with major psycho-behavior maintenance. The hypothesis is that a personalized program combining remote psycho-professional and physical care by digital tools improves functional evaluation in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional care in a day hospital | Active comparator | Other: Common phase, Other: Care in Face to Face1. A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia. 2. A Second phase of 5 weeks of care face to face day hospital of the reconditioning type of 15 sessions. |
| Telecare rehabilitation | Experimental | Other: Common phase, Other: Telecare rehabilitation1. A common face to face day hospital, combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia. 2. A Second phase of 5 weeks of Telecare rehabilitation of the reconditioning type of 15 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic low back pain (evolution of more than 3 months)
- Patient treated for this pathology in a multidisciplinary program
- Dallas score > 50% in anxiety/depression and sociability dimensions
- Patient who has given free and informed consent to participate in the research
- Patient affiliated to a social security scheme or beneficiary of such a scheme.
Key exclusion criteria (8 listed)
- Recent spine surgery (< 3 months at inclusion visit)
- Cardiovascular risk factor contraindicating sports practice.
- Severe psychiatric pathology
- Low back pain of tumoral or inflammatory origin.
- Associated motor or sensory, neurological impairment.
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 |
|---|---|---|
| Common phaseA common face to face day hospital combining physical therapies with psychotherapeutic support such as Cognitive Behavioral Therapy to combat kinesiophobia. | Other | Conventional care in a day hospital, Telecare rehabilitation |
| Telecare rehabilitationA Second phase of 5 weeks of telecare rehabilitation of the reconditioning type of 15 sessions. | Other | Telecare rehabilitation |
| Care in Face to FaceA Second phase of 5 weeks of care in face to face day hospital of the reconditioning type of 15 sessions. | Other | Conventional care in a day hospital |
Primary outcome
Oswestry Disability Index
Time frame: 3 months after the end of rehabilitation
Overall score of the Oswestry self-questionnaire. The score goes from 0 to 50, It will be converted into a percentage (Score ODI). Zero is equated with no disability and 100 is the maximum disability possible.
14 secondary outcomes
Economic efficiency
Time frame: At the end of the rehabilitation
Spontaneous pain
Time frame: At the end of the rehabilitation and 3 month after.
Overall flexibility
Time frame: At the end of the rehabilitation and 3 month after.
Range of motion of lumbar mobility
Time frame: At the end of the rehabilitation and 3 month after.
Sub pelvis muscle flexibility.
Time frame: At the end of the rehabilitation and 3 month after.
Quadriceps strength
Time frame: At the end of the rehabilitation and 3 month after.
Endurance of trunk extensors
Time frame: At the end of the rehabilitation and 3 month after.
Endurance of trunk flexors
Time frame: At the end of the rehabilitation and 3 month after.
Anxiety and depression
Time frame: At the end of the rehabilitation and 3 month after.
The kinesiophobia
Time frame: At the end of the rehabilitation and 3 month after.
Functional abilities
Time frame: At the end of the rehabilitation and 3 month after.
Socio professional criteria
Time frame: 3 months after the end of rehabilitation
Compliance
Time frame: At the end of the rehabilitation
Acceptability
Time frame: At the end of the rehabilitation program and 3 months after.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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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.
Jephté Houedakor principal investigator
Pôle Saint Hélier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common phase, Telecare rehabilitation and Care in Face to Face in people with Low Back Pain, run by Pôle Saint Hélier at 1 site in France.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 27 Dec 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oswestry Disability Index (time frame: 3 months after the end of rehabilitation). 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 27 Dec 2024.