Biomedical subjects

A J Köke

Publications and source records attributed to A J Köke.

6 recordsLinked to original sources

PubMed2000

Behavioral-graded activity compared with usual care after first-time disk surgery: considerations of the design of a randomized clinical trial.

OBJECTIVE: To present the design of a trial on the effectiveness of a behavioral-graded activity model. DESIGN: Randomized clinical trial. PATIENTS: Patients undergoing first-time lumbar disk surgery who still have low-back pain at the 6-week neurosurgical consultation. INTERVENTIONS: A patient-tailored behavioral-graded activity program that is based on operant therapy. The key elements of this program are baseline measurements, goal-setting, and time-contingency. This program is compared with usual care in physiotherapy, which is pain-contingent. OUTCOME MEASURES: Primary measures are the patient's global impression of the effect and their functional status. Secondary measures are kinesiophobia, catastrophizing, pain, main complaint, range of motion, and relapses. The direct and indirect costs will also be assessed. The effect measures are rated before randomization and 3, 6, and 12 months later. DISCUSSION: Several trials have been conducted on the effectiveness of behavioral treatments. Subjects were always patients with chronic low-back pain. In this trial, we apply such a treatment in patients after first-time disk surgery in a primary care setting.

Adaptation, Psychological↗

PubMed1997

Efficacy of traction for nonspecific low back pain. 12-week and 6-month results of a randomized clinical trial.

STUDY DESIGN: A randomized clinical trial. OBJECTIVES: To assess the efficacy of motorized continuous traction for low back pain. SUMMARY OF BACKGROUND DATA: The available studies on the efficacy of lumbar traction do not allow clear conclusions because of severe methodologic flaws. The current trial aimed to overcome these shortcomings. METHODS: Patients with at least 6 weeks of nonspecific low back pain were selected. High-dose traction was compared with sham (or low-dose) traction. Sham traction was given with a specially developed brace that becomes tighter in the back during traction. This was experienced as if real traction were exerted. The patients and the outcome assessor were unaware of treatment allocation. Outcome measures were: patient's global perceived effect, severity of main complaints, functional status, pain, range of motion, work absence, and medical treatment. Results for the outcome measures at 12 weeks and 6 months after randomization are presented. RESULTS: One hundred and fifty-one patients were randomly allocated to one of the two treatment methods. Intention-to-treat analysis of the 12-week and 6-month results showed no statistically significant differences between the groups on all outcome measures: all 95% confidence intervals included the value zero. The number of patients lost to follow-up study was very low. Other analyses showed the same results. CONCLUSIONS: Most common flaws of earlier studies on traction therapy could be overcome. This trial did not support the claim that traction is efficacious for patients with low back pain.

Adult↗

PubMed1995

Efficacy of traction for non-specific low back pain: a randomised clinical trial.

Previous trials to assess the efficacy of lumbar traction for back pain have been methodologically flawed. To avoid these shortcomings, we conducted a randomised controlled trial in which high-dose traction was compared with sham traction. The sham traction was given with a specially developed brace that tightens in the back during traction. To the patient, the experience is that of traction. The patients and outcome assessor were blinded for the assigned treatment. 151 patients with at least six weeks of non-specific low back pain were randomised. Intention to treat analysis showed no differences between the groups on all outcome measures (patients' global perceived effect, severity of main complaints, functional status and pain); all 95% confidence intervals included the value zero. The number of withdrawals from treatment, loss to follow-up, and protocol deviations was low. Consequently, the per-protocol analysis showed results similar to the intention to treat analysis. Subgroup analyses did not show any group for which traction might seem promising. Our data do not support the claim that traction is effective for patients with low back pain.

Adult↗

PubMed1995

Measuring the functional status of patients with low back pain. Assessment of the quality of four disease-specific questionnaires.

STUDY DESIGN: This study was a literature review of the quality of four disease-specific functional status questionnaires for patients with low back pain: Oswestry; Million; Roland; and Waddell disability questionnaire. OBJECTIVES: The questionnaires were evaluated in terms of general description, scale structure, reliability, validity, responsiveness, and clinical research applications. SUMMARY OF BACKGROUND DATA: Functional status is an outcome of great interest for clinical trials of low back pain. METHODS: A computer-aided search was conducted of articles published between 1981 and 1993 and references given in selected relevant publications. Articles were selected if at least one of the four functional status questionnaires was used or if the authors gave relevant information about the methodology of these questionnaires. RESULTS: There was not enough information available about the criteria of item selection used for the development of the questionnaires. The test-retest reproducibility of the questionnaires seemed satisfactory. The Oswestry and Roland disability questionnaires have been used and evaluated more frequently than the Million and Waddell. Therefore, we can be more certain about the validity and responsiveness of the former pair of questionnaires. CONCLUSION: In the absence of a gold standard, direct comparisons of evaluative functional status questionnaires in a single patient group are needed. Through direct comparisons, comparative validity and responsiveness can be assessed. Functional status measures are not currently used in many settings in which they would be valuable. It is important to encourage their wider use in clinical trials. Additional research is needed to compare and improve the existing questionnaires.

Activities of Daily Living↗

PubMedDate not supplied

A patient-specific approach for measuring functional status in low back pain.

BACKGROUND: Activities and their importance for daily living vary widely between patients. Patient-specific measurement of functional status means that the evaluation is focused on activities that an individual patient selected as main complaints. OBJECTIVE: To develop and to evaluate a patient-specific approach for measuring functional status in low back pain. STUDY DESIGN: A cohort of 150 patients was measured at baseline and 12 weeks later. METHODS: The feasibility of the patient-specific approach was evaluated in patients with nonspecific low back pain. We used effect size statistics to evaluate responsiveness in terms of sensitivity to change and specificity to change. RESULTS: The selection procedure for the main complaint was feasible but labor intensive. The patient-specific approach was able to detect changes in complaints that were highly relevant for the patients. The patient-specific approach appeared to be more sensitive to change but less specific to change compared with other instruments. CONCLUSIONS: On the basis of this study it would be valuable to apply the patient-specific approach in future studies, also with the aim of further evaluation. In the meantime a number of practical problems of the method need to be resolved.

Activities of Daily Living↗

PubMedDate not supplied

The efficacy of traction for lumbar back pain: design of a randomized clinical trial.

OBJECTIVE: To present the design of a trial on the efficacy of lumbar traction. DESIGN: Randomized clinical trial. PATIENTS: Patients with a minimum of 6 wk, nonspecific low back pain. INTERVENTION: High-dose, motorized, continuous traction with a force between 35% and 50% of the total body weight was compared with sham or low-dose traction with a force between 0 and 20% of body weight. The sham traction was given with a specially developed brace that becomes tighter in the back during traction. This is experienced by patients as if traction were exerted. OUTCOME MEASURES: Primary measures were the patient's global impression of the effect and the severity of three main complaints. Secondary effect measures were functional status, pain, range of motion, work absence and recurrences. The effect measures were rated before randomization and 4 wk, 12 wk and 6 months later. CONCLUSION: There have been a number of earlier trials on the efficacy of lumbar traction; they suffer, however, from severe methodological flaws. This trial aimed to avoid these shortcomings.

Analysis of Variance↗