Efficacy of Text-messaging on Activity Limitation in People With Chronic Low Back

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The main aim of this study was to evaluate the medium-term efficacy of an intervention involving personalized, automated text messaging (SMS), following face-to-face rehabilitation sessions, on activity limitation in people with chronic low back pain. We hypothesize that personalized SMS follow-up, following face-to-face rehabilitation sessions, could reduce activity limitation in people with chronic low back pain. Prospective multicenter randomized controlled trial.

Participants in both groups, experimental and comparator will have 4 face-to-face multidisciplinary rehabilitation sessions.

Participants in the 2 groups will have a face-to-face medical-kinesthetic clinical consultation at M3.

Participants in the experimental group will be monitored by personalized SMS messages over 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

People with chronic low back pain (common low back pain, duration of low back pain > 3 months)

People who own a cell phone and have mastered the basics of using it (consulting and sending sms).

Person with a moderate to high self-efficacy for exercise score (SEE score ≥ 31/90).

Patient having signed the study participation consent form. Patient affiliated to a social security scheme or entitled beneficiary

Disqualifiers

Any other pathology affecting postural stability or voluntary active mobility

Contraindication to exercise

Lumbar spine surgery in the 12 months prior to inclusion in the study

Inability to write, speak or read French

Trial design

Design model

Parallel

Treatments tested in this trial

  • SMS

    Procedure/Surgery

    Usual follow-up

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ARM A : SMSExperimental treatment 1 intervention
Group B: ARM B : Usual follow-upActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Activity limitation

Change in score on the Roland Morris Disability questionnaire (RMDQ, 0 no activity limitation; 24, maximum limitation)

Time frame
Month 6 (M6)

Secondary outcomes

1

Activity limitation

Change in RMDQ score

Time frame
M3
2

Physical activity

Change in overall physical activity measured by pedometer: measurement of average daily activity in the 7 days preceding assessments

Time frame
M3 and M6
3

Pain intensity

Change in pain score measured by numerical scale (at the end of face-to-face supervised PEC

Time frame
M3 and M6
4

Quality of life

Change in quality of life measured by the Medical Outcome Study Short Form-12

Time frame
M6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

This trial is not recruiting at the moment. You can still explore other options: