跳至主要内容
临床试验/NCT07818551
NCT07818551尚未招募不适用

Assessment of Pain Perception and the Impact of Central Sensitization on Biopsychosocial Manifestations During Physical Activity in Patients With Chronic Low Back Pain

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Change in Luomajoki tests score

研究概览

简要总结

The goal of this prospective observational study is to evaluate changes in cognitive and behavioural markers associated with central sensitisation between the start and end of an exercise retraining programme on an exercise bike, in adult patients suffering from chronic lower back pain associated with an untreated degenerative spine, worth or without referred pain.

The main changes it will evaluate are:

- Changes in cognitive and behavioural markers associated with central sensitisation between Day 0 and Day 40 during exercise retraining on an exercise bike as part of a rehabilitation programme for chronic low back pain

Participants will undergo the followings:

  • A calibration test used to define moderate exertion on an ergocycle, corresponding to a perceived exertion of 4-5/10 on the modified Borg scale
  • Exercise-induced pain intensity assessment tests to detect changes in the intensity of pain during physical activity and the activity's potential to cause pain, realised on ergocyle
  • Exercise rehabilitation on an ergocycle
  • Final tests to assess cognitive and behavioural markers related to central sensitisation and pain intensity, as at baseline.

详细描述

Patients with chronic low back pain who are scheduled to receive care at the Musculoskeletal Rehabilitation Unit of the Cornouaille Rehabilitation Center in Concarneau for low back pain rehabilitation-either through a group program on a part-time inpatient basis or an individual program on a full-time inpatient basis-will be considered for inclusion in the study.

Eligible patients will be enrolled after the investigator has provided them with comprehensive verbal and written information, conducted initial assessments, verified the inclusion and exclusion criteria, and obtained signed informed consent from the patients. For inpatients, verification of inclusion and exclusion criteria will take place on the day of admission to the Concarneau PRC during the initial evaluation.

Upon admission, the patient is assessed according to standard criteria for the management of patients with low back pain (measurements of spinal mobility: Fingers-to-Floor Distance (FFD), spinal inclinometry in flexion and extension, lateral bending, Schober's test, muscle strength assessment: Shirado and Sorensen tests, measurement of hamstring and quadriceps hyperextensibility), to which are added the Oswestry Questionnaire to assess disability related to low back pain, the CSI questionnaire, which assesses symptoms of central sensitization, and an evaluation of various cognitive-behavioral markers related to central sensitization, including sensitization due to motor disorders (Luomajoki tests), sensitization due to kinesiophobia (Tempa Scale of Kinesiophobia and KINAP), and sensitization due to catastrophizing (Pain Catastrophizing Scale).

After enrollment, patients will undergo a calibration test on an exercise bike on Day 1 to determine the power required to maintain a constant moderate effort corresponding to an intensity of 4-5/10 on the modified Borg scale. Then, to assess the pain-inducing potential of exercise on an ergocycle, they will perform two tests (on Day 3 and Day 5) to evaluate changes in pain during moderate, sustained exercise.

During their rehabilitation for low back pain, patients undergo exercise retraining on an ergocycle. From Day 8 through Day 40 (3 times per week, on Mondays, Wednesdays, and Fridays), the patients' perceived exertion will be assessed at the end of each ergometer session to verify that they are indeed maintaining a constant moderate level of exertion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients, ages 18 through 75 inclusive, admitted to the Musculoskeletal Rehabilitation Unit at the Concarneau Regional Hospital
  • Chronic low back pain due to degenerative spine disease that has not been treated surgically, with or without referred pain
  • Low back pain intensity of 4/10 or less on the EVA scale
  • Pain lasting more than 12 months (= critical period for cerebral impairment)
  • Oswestry score between 21% and 40%
  • CSI score of 33/100 or higher for women and 25/100 or higher for men
  • Patients enrolled in or covered by a social security program
  • Patients who have signed a consent form

排除标准

  • Patients with acute low back pain of traumatic or neoplastic origin
  • Patients with a contraindication to moderate-intensity physical activity (Borg 4-5/10 on the modified Borg scale)
  • Inability to participate in sessions due to pain unrelated to low back pain or a disability
  • Pregnant or breastfeeding patients
  • Patients under legal guardianship or conservatorship

研究组 & 干预措施

Exercise rehabilitation on an ergocycle

Other

Exercise rehabilitation on an ergocycle

干预措施: Exercise rehabilitation on an ergocycle (Other)

结局指标

主要结局

Change in Luomajoki tests score

时间窗: Baseline and Day 40

The Luomajoki test consists of six movement control tests assessing lumbar movement control. The score is calculated as the number of positive tests and ranges from 0 to 6. Higher score is worse outcome.

Change in Tampa Scale of Kinesiophobia

时间窗: Baseline and Day 40

The Tampa Scale of Kinesiophobia is a questionnaire used to assess kinesiophobia, defined as the fear of movement. It consists of 17 items, each rated on a 4-point scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The score is calculated as the sum of the 17 items and ranges from 17 to 68. Higher score is worse outcome.

Change in KINAP score

时间窗: Baseline and Day 40

The KINAP consists of presenting participants with photographs illustrating physical and sports activities. For each photograph, participants are asked to rate, on a scale from 0% to 100%, the intensity of their fear regarding potential negative consequences (e.g., pain). The total score is calculated as the mean of the ratings provided for all photographs and ranges from 0% to 100%. Higher scores indicate greater fear and represent a worse outcome.

Change in Pain catastrophizing scale

时间窗: Baseline and Day 40

The Pain Catastrophizing Scale is used to assess the tendency to exaggerate the threat of pain, ruminate about pain, and experience feelings of helplessness in relation to pain. It consists of 13 items, each rated from 0 ("not at all") to 4 ("all the time"). The total score is calculated as the sum of the scores of the 13 items and ranges from 0 to 52 Higher score is worse outcome.

次要结局

  • Pain score(Day 3, 12 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 3, 6 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 3, 9 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 3, before cycle ergometer test initiation)
  • Pain score(Day 3, 3 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 3, 15 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 3, 18 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 3, 21 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 3, 24 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 3, 27 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 3, 30 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 5, before cycle ergometer test initiation)
  • Pain score(Day 5, 3 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 5, 6 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 5, 9 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 5, 12 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 5, 15 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 5, 21 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 5, 24 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 5, 27 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Day 5, 30 minutes after cycle ergometer test initiation, if applicable)
  • Pain score(Baseline)
  • Luomajoki tests score(Baseline)
  • Tampa Scale of Kinesiophobia(Baseline)
  • KINAP score(Baseline)
  • Pain catastrophizing scale(Baseline)
  • Change in pain score(Baseline and Day 40)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验