Determining the Effectiveness of a Novel Phototherapy for the Treatment of Knee Osteoarthritis: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Monitoring Treatment Fidelity
研究概览
简要总结
Light therapy (phototherapy) has previously been shown to help reduce pain for people with musculoskeletal pain conditions, such as knee osteoarthritis (OA). A new phototherapy has been developed that allows for customizing the intensity of light based on patient characteristics, such as the patient size and skin type. This new phototherapy approach needs to be evaluated to determine its effects. This study has been planned to determine how effective the new phototherapy is, but first it needs to be determined whether the study plans are feasible. This study will determine the feasibility of the full study by pilot testing the methods for the full trial with a group of 20 people with knee osteoarthritis. Participants will be randomly assigned to either receive the new phototherapy approach or a placebo phototherapy twice/week for four weeks. Pain and function will be measured over the four week treatment period and 12-weeks follow-up.
详细描述
Invitalize has developed the High Intensity Physio Light (HIPL) Therapy™, a phototherapy method that utilizes an emission wavelength spectrum that has been identified for treatment of musculoskeletal disorders (MSD) such as OA.
Design: Double (patient and investigator) blind, parallel group, pilot randomized control trial with 1:1 allocation ratio to HIPL Therapy™ or placebo control.
Recruitment: For the pilot, 20 adults who have been diagnosed with knee osteoarthritis (OA) of any duration will be recruited to participate in this study at Queen's University. Participants will be recruited from two primary care practices in Kingston, Ontario.
Randomization and allocation concealment: Participants will be randomized to either the placebo or control group using a computer generated random number generator. The allocation sequence will be recorded on cards placed in sealed, opaque envelopes. Allocation will be concealed until after the initial assessment is completed. Patients and investigators will remain blinded throughout the trial.
The HIPL Therapy™ group will receive phototherapy in addition to an education and exercise intervention with a physiotherapist twice weekly for four weeks. Participants will lay in a relaxed position on a therapy plinth with the light applied to the affected knee for 20 minutes. In the case of bilateral knee OA, the treatment time will be doubled and applied to both knees with an intensity setting aimed at delivering 150 mW/cm2.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomized using a computer generated random number generator. The allocation sequence will be recorded on cards placed in sealed, opaque envelopes. Allocation will be concealed until after the initial assessment is completed. At this point the research assistant (physiotherapist) will open the sealed envelope, which will indicate either Group A or Group B, then initiate the phototherapy session by pressing on the corresponding button for Group A or B, which will deliver the appropriate phototherapy intensity for the respective group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking adults (>18 years of age)
- •Provided with a diagnosis of knee OA by a physician
- •Self-report of having experienced pain and disability related to knee OA for at least 6 months.
排除标准
- •Skin conditions in which application of phototherapy may be contra-indicated (skin cancer, people receiving radiation therapy)
- •History of total joint arthroplasty of the affected knee
- •Red flags suggestive of non-musculoskeletal etiology (i.e. fever/chills, unrelenting night pain, multi-segmental or bilateral loss of sensation, sudden unexplained weight loss).
结局指标
主要结局
Monitoring Treatment Fidelity
时间窗: Through study completion (16 weeks)
Fidelity was measured through an audit of the fidelity checklist and reported as a proportion of intervention components delivered in alignment with the protocol. An a-priori acceptable level of fidelity was considered 80% for each component of the intervention among participants that attend each visit.
Retention Rate
时间窗: Through study completion (16 weeks)
Retention will be assessed by attrition rate, with \<20% attrition at 3-month follow-up (16 weeks) considered indicative of feasibility with our current protocol.
Feasibility of Assessment Procedures: completion rate
时间窗: Through study completion (16 weeks)
Feasibility of the assessment procedures will be measured by completion rate of outcome measures. As recommended for pilot studies, we set criteria a priori for acceptable completeness and considered \>80% of all assessment items completed.
Recruitment Rate
时间窗: Baseline
The feasibility of patient recruitment will be determined by the overall recruitment rate. The full trial will be considered feasible with our current recruitment methods if, during the pilot study, an average recruitment rate of at least 3 patients per week is achieved. This recruitment rate will allow us to exceed the 168 participants needed for a fully powered trial in a 56 week recruitment period. The findings of this study will inform whether this preliminary plan is feasible or if additional sites are needed.
Feasibility of Research Assistant (RA) Training: rating
时间窗: Baseline
Feasibility of training the RA who will implement the phototherapy intervention will be evaluated a rating of self-efficacy (0-10) for delivering the intervention, where a lower score would indicate a lower rating of preparedness for delivering the intervention and a higher score would indicate a higher rating of preparedness to deliver the intervention.
次要结局
- Global Rating of Change in Satisfaction with Care(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Change in Physical Function(Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits))
- Global Rating of Change in Pain(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Adverse Events(1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Change in Pain Intensity: VAS(Each clinical visit (twice per week for four weeks))
- Change in Self-Reported Function(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Global Rating of Change in Functional Abilities(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Change in Sensitivity to Physical Activity (SPA)(Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits))
- Monitoring Exercise Adherence(Through study completion (16 weeks))
- Change in Pressure Pain Threshold: Newtons (N)(Baseline and 4 weeks (1st and 8th clinic visits))
研究者
Jordan Miller, PT, PhD
Associate Professor
Queen's University