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?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Allocation concealment:
The results of the allocation sequence are placed in sequentially numbered, opaque, and sealed envelopes by an independent researcher to ensure confidentiality.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: Baseline-6 weeks
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
Oswestry Disability Index (ODI)
时间窗: Baseline-6 weeks
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.
NRS Numeric rating scale for pain
时间窗: Baseline- 6 weeks
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
次要结局
- Short-Form: SF 36-Quality of life(Baseline- 6 weeks)
- Global rating scale(6 weeks)