Assessment of Pain Perception and the Impact of Central Sensitization on Biopsychosocial Manifestations During Physical Activity in Patients With Chronic Low Back Pain (BASICS)
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.
調査の概要
詳細な説明
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.
Patients will be assessed on Day 40 to collect measurements of cognitive-behavioral markers related to central sensitization and pain intensity, as was done at enrollment.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:François GICQUEL
- 電話番号:+33290778080
- メール:gicquelfrancois@hotmail.fr
研究連絡先のバックアップ
- 名前:Mathilde Guillo
- メール:mathilde.guillo@chu-brest.fr
研究場所
-
-
-
Concarneau、フランス、29900
- SMR pôle Réadaptation de Cornouaille
-
コンタクト:
- François GICQUEL
- 電話番号:+33290778080
- メール:francois.giquel@ugecam.assurance-maladie.fr
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の:Exercise rehabilitation on an ergocycle
|
Following enrolment, patients will undergo a calibration test on an ergocycle 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 the ergocycle, they will undertake two tests (on Day 3 and Day 5) to evaluate changes in pain during constant moderate exertion. During their rehabilitation programme for low back pain, patients will undergo exercise retraining on the ergocycle. From Day 8 to Day 40 (three times a week, on Mondays, Wednesdays and Fridays), the patients' perception of exertion will be assessed at the end of each exercise bike session to ensure that they are maintaining a constant moderate level of exertion. Patients will be assessed on Day 40 to collect data on cognitive and behavioural markers related to central sensitisation and pain intensity, as at baseline. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Luomajoki tests score
時間枠: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.
|
Baseline and Day 40
|
|
Change in Tampa Scale of Kinesiophobia
時間枠: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.
|
Baseline and Day 40
|
|
Change in KINAP score
時間枠: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.
|
Baseline and Day 40
|
|
Change in Pain catastrophizing scale
時間枠: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.
|
Baseline and Day 40
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain score
時間枠:Day 3, before cycle ergometer test initiation
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, before cycle ergometer test initiation
|
|
Pain score
時間枠:Day 3, 3 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 3 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 3, 6 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 6 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 3, 9 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 9 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 3, 12 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 12 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 3, 15 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 15 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 3, 18 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 18 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 3, 21 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 21 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 3, 24 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 24 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 3, 27 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 27 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 3, 30 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 3, 30 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 5, before cycle ergometer test initiation
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, before cycle ergometer test initiation
|
|
Pain score
時間枠:Day 5, 3 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, 3 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 5, 6 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, 6 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 5, 9 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, 9 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 5, 12 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, 12 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 5, 15 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, 15 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 5, 21 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, 21 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 5, 24 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, 24 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 5, 27 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, 27 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Day 5, 30 minutes after cycle ergometer test initiation, if applicable
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Day 5, 30 minutes after cycle ergometer test initiation, if applicable
|
|
Pain score
時間枠:Baseline
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Baseline
|
|
Luomajoki tests score
時間枠:Baseline
|
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.
|
Baseline
|
|
Tampa Scale of Kinesiophobia
時間枠:Baseline
|
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.
|
Baseline
|
|
KINAP score
時間枠:Baseline
|
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.
|
Baseline
|
|
Pain catastrophizing scale
時間枠:Baseline
|
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.
|
Baseline
|
|
Change in pain score
時間枠:Baseline and Day 40
|
Pain score will be measured using visual analogic scale.
Score goes from 0 cm to 10 cm.
Higher score is worse outcome.
|
Baseline and Day 40
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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