Evaluation of "Muscle and Articulation Chains GDS Method" Treatment for Inoperable Low Back Pain Patients - a Randomised, Controlled Pilot Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
Our purpose is to conduct a pilot study to evaluate GDS muscle and articulation chain treatment for inoperable spine patients with degenerative changes in the lumbar spine, compared to "standard treatment" (any other chosen treatment). The pilot study will be conducted as a randomized controlled trial (RCT) to investigate feasibility and benefit of GDS muscle and articulation chain treatment on pain, function and quality of life. The pilot study will form the basis for a later full-scale randomized study and the following research questions will be addressed:
- To what extent were the criteria for inclusion in the study suitable?
- How did the recruitment procedure work?
- How did the participants experience GDS treatment?
- To what extent were the selected outcome measures suitable at the different evaluation moments, and which outcome measure tested in this pilot study would be most suitable as primary outcome measure in a full-scale study? (user experience will be included in the evaluation)
- How was the change in the primary outcome measure (Oswestry Disability Index)?
- What will be the estimated time for inclusion of the required number of participants in a full-scale study? (required sample size will be based on strength calculation /saving of the outcome target chosen as primary outcome measure for full scale study) The study is a pilot study with a randomized controlled design, with follow-up after 3-4 months. Thirty patients are recruited and receive baseline examination and respond to the questionnaires before randomization. The patients receive a questionnaire by mail 3-4 months after inclusion (after the treatment is completed for intervention group ). The pilot study will be one-way blinded.
详细描述
Design: randomized, controlled trial with intervention and control arm. Recruitment: Patients are recruited from those relegated from GPs in Vestfold to the spine surgeons at Vestfold Hospital (SIV) for assessment of surgery. Participants who qualify for the study will be contacted by the project staff member (Sidsel Lombardo) who will provide the information about the study. Participants who are interested in participating will be assessed in terms of the study's inclusion and exclusion criteria. If these are met, the participant will be explained what the study is based on in detail, both orally and in writing (appendix in REK application). The participant is then asked if he / she is still willing to participate. They will then undergo the baseline survey, fill in the forms and then sign the consent declaration. Afterwards they are randomized to GDS treatment or standard therapy. Participants have the opportunity to quit along the way without affecting their health care and regular treatment.
Inclusion criteria
- Women and men aged between 35 to 75 years, with chronic (> 3 months) low back pain, with or without irradiation in legs.
- Degenerative changes in the lumbar spine verified on MR. Exclusion criteria
- Severe psychiatric disorder
- Comorbidity that prevents the patient from performing exercises and gradually increasing general activity when the back / leg function permits it.
- Already had surgery with fixation of the lumbar spine.
- Pregnancy
- Being in process of assessing disability insurance or economic compensation for health reasons.
Randomization procedure: After baseline survey and answered questionnaire, participants will be randomized to intervention and control group using a data generated randomization sequence at a 1: 1 ratio. Statisticians at the Musculoskeletal Health Research Group (MUSKHealth.com) at OsloMet will assist with the randomization sequence.
Blinding: In this study, one cannot blind the participants nor the treating physiotherapist for which treatment they are receiving. However, research staff who collect and process data at the 3-4 month follow-up will be blinded to who is randomized to the intervention and control groups, respectively.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator and outcome assessor will be masked for randomisation. It is not possible to mask the patient and treatment provider.
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, age 35-75 years, with cronic (>3 months) LBP, may have irradiation in legs.
- •Degenerative changes in the lumbar spine verified on MR.
排除标准
- •Severe psychiatric disorder.
- •Comorbidity that prevents the patient from performing exercises and gradually increasing general activity when the back /leg function gradually allows it.
- •Already had surgery with fixation of lumbar spine.
- •Being in process of assessing disability insurance or economic compenastion for Health reasons.
- •Pregnancy
结局指标
主要结局
Oswestry Disability Index
时间窗: 4 months
Measures activity limitations
次要结局
- The Keele Start Back screening tool(4 months)
- EQ-5D-5L(4 months)
- Visual analogue scale (VAS)(4 months)
研究者
Sidsel Lombardo
Physiotherapist
The Hospital of Vestfold