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临床试验/NCT04715789
NCT04715789Unknown不适用

EFFECT OF COGNITIVE BEHAVIOURALTHERAPY IN TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Arabic ODI for function

研究概览

简要总结

To explore the effect of adding cognitive-behavioral therapy to physical therapy interventions in patients with chronic non-specific back pain.

详细描述

Studies suggest that patients with LBP benefited when standard rehabilitation approaches were supplemented with graded exercise . There is adequate information to allow clinical implementation of graded exercise by physical therapists, In contrast, there is less information available for physical therapy implementation of graded exposure. LBP rehabilitation based on graded exposure principles Therefore, the purpose of this study is to review the available evidence for graded exposure and to describe physical therapy application of graded exposure for patients enrolled in clinical trial.

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 (Care Provider, Investigator)

盲法说明

The main investigator will perform the physical therapy program after referral by Blind assessor after assessment.

Main investigator start the treatment based on the randomization made by the software after the referral so he will not know the assessment results before and after he treatment and the assessor will not know the randomization results and the patient group selected for treatment

So this procedures will be done by double blind procedure for the main investigator and research assistance.

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patient's age between 25-40 years.
  • •Patients have persistent Chronic Non-specific LBP for at least 3 months with or without leg pain. Leg pain won't exceeds mechanical behaviors.
  • •Score of 24 fear avoidance questionnaire.
  • •Symptoms of hypersensitivity, secondary punctate or pressure hyperalgesia and fear of movement as a central sensitization symptoms

排除标准

  • •1-History of previous back surgery. 2- History of previous hip, knee or ankle surgeries. 3- Systemic inflammatory diseases. 4-Tumors. 5-Red flags of back pain 6-Patients with disc pathology and radicular pain 7- spinal fracture or spinal surgery 8- systemic disease or TB of spine widespread constant non-specific pain disorder, pain without a clear mechanical behavior

研究组 & 干预措施

physical therapy intervention

Experimental
  1. core stability exercises:

  2. Multifidus exercises

  3. Frontal & Side Plank exercise

  4. Pelvic floor exercises

  5. abdominal exercises

  6. Strengthening exercises

  7. Bridging

  8. straight leg raise

  9. gluteus medius strength

  10. gluteus maximus strengthening for about 20 min to 30 min to strength back and proximal hip control muscles

干预措施: graded exposure and activity (Behavioral)

graded exposure and graded activity in addition to phycal therapy intervention

Experimental
  1. Graded exposure:This approach followed a model where the patient was gradually exposed to previously pain provocative, feared and or avoided tasks. These activities are started at a diminished level that elicits minimal amounts of fear and then gradually increased to situations that elicit larger amounts of fear patients are asked to create a hierarchy of feared activities. The exposure starts with the least feared activity, and the therapist helps the patient appraise the exposure and its consequences and then address irrational and counterproductive beliefs, leading to reductions in the anxiety associated with the activity
  2. Graded activity exercises: The new postural and movement behaviors were integrated into each person's nominated pain provocative functional activities linked to their goals in order to generalize learning and build self-efficacy the program focuses on functional activities for about 10 min before physical therapy program (strengthening)

干预措施: graded exposure and activity (Behavioral)

结局指标

主要结局

Arabic ODI for function

时间窗: 5 minutes

a)ODI ASSESMENT: Patient-completed questionnaire which gives a percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. In pre session and after end of sessions This Questionnaire examines perceived level of disability in 10 everyday activities of daily living. The 6 statements are scored from 0 to 5 with the first statement scoring 0 through to the last at5 If all 10 sections are completed the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32% Scores: 1- (0% to 20%): minimal disability 2-(21%-40%: moderate disability) 3- (41%-60%): severe disability 4-(61%-80%: crippled) 5-(81%-100%) These patients are either bed-bound or exaggerating their symptoms

次要结局

  • Numerical rating scale(5 minutes)
  • Tape measurement(5 minutes)
  • Fear avoidance belief questionnaire(5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mohmed yehia elabd hasan

phyisical therapist at qena oncology center

Cairo University

研究点 (1)

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