A Randomized Pragmatic Trial About the Effectiveness of an App Based Relaxation Technique for Patients With Chronic Low Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Low Back Pain
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.
Detailed Description
Objective: To evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone. Study design: Open single-centered randomized two-armed pragmatic trial. Participants: 220 patients aged 18-65 years with chronic (\>12 weeks) low back pain and a mean pain score ≥ 4 on a Numeric Rating scale (NRS) in the last week before randomization who will be randomly allocated to two groups (relaxation, usual care alone as waiting list) Intervention: Participants apply either a daily 15-minute relaxation exercise guided by a smartphone application ("app"). or apply no additional intervention. The exercise should be applied daily, (minimally five days per week) for 6 months. The app contains audios to guide autogenic training, muscle relaxation training and guided imagery. On a daily basis, participants can select one of the three exercises which they want to apply. Main outcome measure: The primary outcome is the mean pain intensity after 3 months measured by the daily pain intensity on the NRS.
Investigators
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •female or male
- •18-65 years of age
- •chronic low back pain for at least 12 weeks
- •if additional back pain is reported, low back pain has to be predominant
- •intensity of the average low back pain ≥ 4 on the numeric rating scale (NRS) in the last week
- •presence of a smartphone (iphone, Android phone) and willingness to do data entry through a smart phone application (App)
- •willingness to be randomized, to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and diaries provided by an App physical and mental ability to participate in the study
- •written and oral informed consent
Exclusion Criteria
- •low back pain caused by a known malignant disease
- •neck pain caused by trauma
- •known rheumatic disorder
- •history or planned surgery of the spinal column of the low back in the next 6 months
- •known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc
- •regular intake of analgesics (\>1x per week) because of additional diseases
- •intake of centrally acting analgesics
- •known severe acute or chronic disorder, that do not allow participation in the therapy
- •other known diseases, that do not allow participation in the therapy
- •known alcohol or substance abuse
Outcomes
Primary Outcomes
Primary outcome is the mean pain intensity over 3 months measured by the daily pain intensity on the Numeric rating scale (NRS)
Time Frame: 3 months
Secondary Outcomes
- Pain acceptance(3 and 6 months)
- Stress(3 and 6 months)
- Suspected adverse reaction(3 and 6 months)
- medication intake(3 and 6 months)
- Mean pain intensity measured by the daily pain intensity on the NRS(6 months)
- Mean pain intensity measured weekly as the average pain intensity of the last seven days on a NRS(3 and 6 months)
- Number of Serious adverse event(3 and 6 months)
- Number of sick leave days(3 and 6 months)