Effect of Teletherapy-supported Training on Nursing Students

Low Back Pain Clinical Trial

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295276
• Other study ID #: HSOsnabruck
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Hochschule Osnabruck
• Contact: Susan Armijo-Olivo, PhD
• Phone: 015223170807
• Email: susanarmijo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Back Pain
• Neck Pain

Intervention

Other:
• teletherapy-guided exercise programme
Exercise program guided by online sessions. Subjects perform this exercise program three times a week at home, so that they complete four sessions per week for six weeks. The duration of a session is approximately twenty minutes. There are six exercises with three sets and about fifteen repetitions. Subjects in the treatment group also receive an instructional video. The subjects keep a diary in which they record their adherence to the treatment protocol at home. At the beginning of the intervention and after the sixth week, participants are assessed with ODI, NDI and SF36-Short and NRS-11 scales. At the end, we use the Global Rating Scale.
• Waiting list/control intervention/delayed teletherapy intervention
Subjects in the control group will be advised to maintain their daily routine but will be asked to refrain from other treatments to avoid co-interventions during the 6-week study period. However, the use of painkillers such as non-steroidal anti-inflammatory analgesics (NSAIDs) taken by study participants in all groups for more than 3 months is allowed and will be documented (taking a pragmatic approach). Any change in medication will be monitored and documented by the PT at each visit.

Locations

Country	Name	City	State
Germany	Diakonie Pflege Schule	Osnabrück	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Hochschule Osnabruck

Country where clinical trial is conducted

Germany, 

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* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index (NDI)	10 questions with possible answers ranging from "no pain" to "the worst pain you can imagine", questions for pain intensity, personal hygiene, lifting, reading, headaches, concentration, work, driving, sleeping and the last item leisure activities and recreation.; Rating: Mild complaints 0 points, the most severe complaints with a maximum of 5 points. Maximum score 50 points.; Score is divided by the possible total score. This value is multiplied by 100% to obtain the score. o (Current restriction : 50) X 100% = score in the NDI <=8% mild symptoms. >40 has very severe symptoms	Baseline-6 weeks
Primary	Oswestry Disability Index (ODI)	Extent of pain-related functional limitations in people with back pain. 10 questions with six possible answers each: Pain intensity, self-care, lifting, walking, sitting or standing, sleeping, sex life, social life and traveling.; Answer options range from "no restrictions due to pain" to "greatest perceived restriction of an activity due to pain".; Evaluation: Points achieved ( )/max. points (50) x100 = % Interpretation: 0% = no restriction, 100% = max. restriction.	Baseline-6 weeks
Primary	NRS Numeric rating scale for pain	The Numerical Rating Scale for Pain (NRS) is usually between 0 and 10, with 0 being "no pain" and 10 being "the worst pain imaginable" In a numerical rating scale question, respondents are asked to rate their perceived pain on a predetermined numerical scale. The scale is an ordered number scale with a fixed range that represents the extremes of the measured value	Baseline- 6 weeks
Secondary	Short-Form: SF 36-Quality of life	SF 36-Quality of life he SF-36 questionnaire (Short Form Health 36) is a questionnaire on quality of life.; For information on the general. 8 different dimensions Vitality - Physical functioning - Physical pain - General health perception - Physical role functioning - Emotional role functioning - Social role functioning - Psychological well-being For the evaluation, all answers are first converted into predefined points with the help of an evaluation key. The average value of all questions of the respective health dimension	Baseline- 6 weeks
Secondary	Global rating scale	The Global Rating Scale (GRS) is described as a useful measurement tool with the aim of assessing clinical competence at a general level based on specific word dimensions, measuring instrument to determine the effect of the intervention . This scale is used by us in the study to assess the changes experienced by the patient as a result of treatments or other interventions. Our subjects are asked to rate the change they have experienced after treatment for neck pain and low back pain (LBP) pain using a Global Rating Scale (GRS). Therefore, this questionnaire is only used for the final measurement.; Participants rate their state of health now compared to before the intervention.; The values range from -7 to 7. It is measured with -7 as "very much worse", 0 as "unchanged" and 7 as the maximum best value "very much better".	6 weeks

External Links

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