Effect of Teletherapy-supported Training on Nursing Students

NCT06295276 | Completed

• 1 other identifier: HSOsnabruck
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain; Neck Pain

Keywords

teletherapy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Short-Form: SF 36-Quality of life

  Baseline- 6 weeks

• Global rating scale

  6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

a six-week muscle training program with 5 exercises 3 times a week as video-guided exercises for homework alone and the same exercises once a week guided by Zoom. The program lasts 6 weeks

Other: teletherapy-guided exercise programme

Waiting list/control intervention/delayed teletherapy intervention

OTHER

After the 6 weeks, participants are offered the opportunity to take part in the intervention program (see above)

Other: Waiting list/control intervention/delayed teletherapy intervention

Interventions

teletherapy-guided exercise programme OTHER

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.

Intervention

Waiting list/control intervention/delayed teletherapy intervention OTHER

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.

Waiting list/control intervention/delayed teletherapy intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hochschule Osnabruck: lead

Study Sites (1)

Diakonie Pflege Schule

Osnabrück, Lower Saxony, 49078, Germany

Location

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Related Links

• Appendices\_additional\_information

MeSH Terms

Conditions

Low Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Allocation concealment: The results of the allocation sequence are placed in sequentially numbered, opaque, and sealed envelopes by an independent researcher to ensure confidentiality.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel comparative randomized controlled trial

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: January 31, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)