Protocol for the Evaluation of the Effects of Limiting Verbal Complaints on Pain and Pain Catastrophizing in Individuals With LBP Who Are in a State of Central Sensitization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale for Pain
研究概览
简要总结
The primary goal of this study is to examine the effects of limiting complaints on pain and pain catastrophizing (PC) in individuals with low back pain (LBP) who are in a state of central sensitization (CS).
The study will be performed on individuals who have LBP and are in a state of CS. CS is classified as a type of pain which has the following dominant features: pain that is disproportionate to the nature or extent of injury/pathology; disproportionate, non-mechanical, unpredictable pattern of pain provocation in response to aggravating/easing factors; strong association with maladaptive psychological factors
; diffuse/non-anatomic areas of pain/tenderness to palpation. These criterion have been demonstrated to have discriminative validity for diagnosing CS.
详细描述
This will be a multicenter, randomized (1:1) controlled trial with an experimental and control group. The control group will be treated as the clinician wishes and will be given a bracelet to wear during treatment. The experimental group will be treated as the clinician wishes as well as given a bracelet and a journal with the following instructions:
The goal of this bracelet is to help you recognize your verbal complaints, which we believe may be related to your pain. We are asking that you wear it and follow these rules:
- Place the bracelet on either wrist. Please identify in the journal which wrist you have placed it on and the date.
- If you verbally complain about Anything, including your pain, switch it to the other wrist, identify the date, wrist switched to, and complaint. Internal complaints and thoughts are allowed.
- Indicate if this complaint made you feel better, worse or the same.
We want you to attempt to limit your complaints through altering your wording to express a way in which you could make your situation better. For example, instead of saying "it is way too cold outside" say, "I could have worn more clothes today and I would be less cold".
Participating clinicians will complete a power-point educational session in which they will be trained on the randomization process, the rules of the bracelet and goals of this study. A short education piece on central sensitization will also be provided. Each clinician will consent that they have successfully completed this and understand all aspects of participation. We will also require the clinician to complete a short questionnaire that will ask the following questions:
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Individuals over the age of 18 who present to physical therapy with a clinical diagnosis of non-specific low back pain.
- •Their pain must also have the one of the following characteristics:
- •2a.the pain is disproportionate to the nature or extent of injury/pathology AND/OR 2b.the pain is disproportionate, non-mechanical, and unpredictable in response to aggravating/easing factors AND/OR 2c.the pain has a strong association with maladaptive psychological factors AND/OR 2d. the pain is diffuse/non-anatomic areas of pain/tenderness to palpation.
排除标准
- •Any red-flags indicating the low back pain is caused by non-musculoskeletal pathology
- •Pain whose origin could be better defined as noceptive (intermittent and sharp with movement or mechanical provocation; pain localized to the area of injury or dysfunction; clear, proportionate mechanical/anatomical nature to aggravating and easing factors; pain described as shooting, burning, sharp, electric-like; pain in association with other dysesthesias; night pain/disturbed sleep; antalgic postures/movement)
- •Pain whose origin could better be defined as peripheral neuropathic (history of nerve injury, pathology or mechanical compromise; pain in a dermatomal or cutaneous distribution; pain/symptoms provocation with movement tests that move or compress neural tissue (ex. SLR)
结局指标
主要结局
Visual Analogue Scale for Pain
时间窗: week 1,4,12, 26
This is the visual analogue scale for pain which is routinely used in Physical Therapy practice. The multiple time frames are to assess a change in subjective pain values throughout the study.
次要结局
- Pain Catastrophizing Scale(Weeks 1,4,12,26)
研究者
Joseph Brence
Physical Therapist
Keystone Rehabilitation Systems