Clinical trial NCT06295276: Effect of Teletherapy-supported Training on Nursing Students
Official title: Does a Teletherapy-guided Exercise Programme Improve Pain Intensity, Disability, and Quality of Life in Nursing Students With Back and Neck Pain Compared to a Control Group?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Neck Pain
Keywords: teletherapy
Lead sponsor: Hochschule Osnabruck
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel comparative randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group.

The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week.

The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale

Detailed description: Intervention of interest: As already mentioned, the protocol of interest is an exercise program supported by online sessions (teletherapy). Exercise routines related to the individual areas of the spine as a functional unit were created based on evidence-based conclusions, especially considering muscle chain activity and appropriate loading parameters

The teletherapy exercise program is carried out once a week via ZOOM by a physiotherapist with thirty years of experience in treating patients with musculoskeletal disorders. Participants are also encouraged to carry out this exercise program themselves at home three times a week so that they have four sessions per week for six weeks. The duration of each session is approximately twenty minutes per session. There are six exercises with three sets and about fifteen repetitions within thirty seconds per set. Exercise description with rationale for exercise selection"). Subjects in the treatment group will also receive a video, rhythm and music files and written materials to help them follow the exercise routines at home, as well as a rubber band. Subjects are also asked to keep a diary in which they record their adherence to the home treatment protocol.

At the beginning of the intervention and after the seventh week, the participants are each assessed with the Patient Reported Outcomes (PROMs), namely ODI, NDI and SF36 short and NRS 11-point scales. At the end of the intervention, participants are interviewed using the Global Rating Scale. Below is a brief description of these instruments.

Control group:

Subjects in the control group will be advised to maintain their daily routine but will be asked to refrain from other treatments such as physical Therapy (PT), osteopathy, chiropractic as well as other therapeutic exercise (TE) therapies to avoid co-interventions during the 6-week study period. However, pain medication taken by study participants for more than 3 months in all groups, such as non-steroidal anti-inflammatory analgesics (NSAIDs), will be permitted and documented (taking a pragmatic approach). Any change in medication will be monitored and recorded by the PT at each visit.

Eligibility criteria: Inclusion Criteria:

* Nursing students between 18 and 60 years of any gender
* Self-reported chronic neck and back pain in the last six months (more than three months as described by the International Association for the Study of Pain (IASP)).
* Speak and understand German

Exclusion Criteria:

Surgery in the last year on the spine, cervical, thoracic, or lumbar spine

* Currently on sick leave
* Acute back pain
* Severe neurological injuries or symptoms
* Acute trauma to the musculoskeletal system
* Renal insufficiency, dialysis
* Severe impairment of the ability to grip with the hand, e.g., rheumatoid arthritis.
* Severe cardiovascular diseases, e.g. heart failure
* Severe respiratory diseases, e.g., Chronic Obstructive Pulmonary Disease-COPD
* Nystagmus
* Falling tendency/balance disorders
* Latex allergy, as rubber band may be made of latex
* Lack of ability to stand, inability to stand safely without the help of a person or object.
* A spine-specific pain therapy drug treatment within the last three months

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: Baseline-6 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline-6 weeks
measure: NRS Numeric rating scale for pain
timeFrame: Baseline- 6 weeks
Secondary outcomes:
measure: Short-Form: SF 36-Quality of life
timeFrame: Baseline- 6 weeks
measure: Global rating scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Osnabrück
country: Germany
facility: Diakonie Pflege Schule
state: Niedersachsen
Study officials:
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