Trial Outcomes & Findings for The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain (NCT NCT00939107)

Results Overview

Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

350 participants

Primary outcome timeframe

two months after treatment

Results posted on

2009-11-19

Participant Flow

We recruited patients from September 2003 through May 2007 among those referred for treatment at a primary care specialist centre in Copenhagen, Denmark.

1969 Patients were screened for eligibility. 1619 Were excluded (580 Were unable to speak and understand Danish, 252 Had comorbidity, 224 Had no peripheralization or centralization, 101 Had previous surgery, 87 Could not be examined, 165 other reasons, 210 Declined to participate)

Participant milestones

Participant milestones
Measure	McKenzie Exercises McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy	Spinal Manipulation Spinal manipulation in combination with information of clinical findings and advice about back care
Overall Study STARTED	175	175
Overall Study 12 Months Follow-up	161	163
Overall Study COMPLETED	161	163
Overall Study NOT COMPLETED	14	12

Reasons for withdrawal

Reasons for withdrawal
Measure	McKenzie Exercises McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy	Spinal Manipulation Spinal manipulation in combination with information of clinical findings and advice about back care
Overall Study Lost to Follow-up	14	12

Baseline Characteristics

The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	McKenzie Exercises n=175 Participants McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy	Spinal Manipulation n=175 Participants Spinal manipulation in combination with information of clinical findings and advice about back care	Total n=350 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	175 Participants n=5 Participants	175 Participants n=7 Participants	350 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	38 years STANDARD_DEVIATION 10.4 • n=5 Participants	37 years STANDARD_DEVIATION 9.4 • n=7 Participants	37 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	92 Participants n=7 Participants	195 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	83 Participants n=7 Participants	155 Participants n=5 Participants
Region of Enrollment Denmark	175 participants n=5 Participants	175 participants n=7 Participants	350 participants n=5 Participants
Number sick-listed Number of patients on sick leave due to LBP	65 participants n=5 Participants	47 participants n=7 Participants	112 participants n=5 Participants
Number sick-listed Number of patients not on sick leave due to LBP	110 participants n=5 Participants	128 participants n=7 Participants	238 participants n=5 Participants
Duration of pain	97 Weeks STANDARD_DEVIATION 230 • n=5 Participants	94 Weeks STANDARD_DEVIATION 181 • n=7 Participants	95 Weeks STANDARD_DEVIATION 210 • n=5 Participants

PRIMARY outcome

Timeframe: two months after treatment

Population: Intention to treat

Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).

Outcome measures

Outcome measures
Measure	McKenzie Exercises n=175 Participants McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy	Spinal Manipulation n=175 Participants Spinal manipulation in combination with information of clinical findings and advice about back care
Disability	6.7 Units on a scale Interval 5.8 to 7.6	5.2 Units on a scale Interval 4.3 to 6.1

PRIMARY outcome

Timeframe: Two months posttreatment

Population: Intention to treat

Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points)

Outcome measures

Outcome measures
Measure	McKenzie Exercises n=175 Participants McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy	Spinal Manipulation n=175 Participants Spinal manipulation in combination with information of clinical findings and advice about back care
Number of Patients With Treatment Success	120 participants	95 participants

SECONDARY outcome

Timeframe: twelve months posttreatment

The back and leg pain questionnaire included three separate 11 point box scales comprising the following items: Low Back Pain (LBP) at the moment, the worst LBP within the past two weeks, and the average level of LBP within the last two weeks. These summed to a total score ranging from 0 points (no back or leg pain at all) to 60 points (worst possible back and leg pain on all items).

Outcome measures

Outcome measures
Measure	McKenzie Exercises n=175 Participants McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy	Spinal Manipulation n=175 Participants Spinal manipulation in combination with information of clinical findings and advice about back care
Pain	15.0 Units on a scale Interval 12.9 to 17.1	12.2 Units on a scale Interval 10.1 to 14.3

SECONDARY outcome

Timeframe: twelve months posttreatment

Population: Number of patients on sick leave due to LBP pre-treatment.

Measured by self-report of beeing on sick leave at the moment because of LBP

Outcome measures

Outcome measures
Measure	McKenzie Exercises n=66 Participants McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy	Spinal Manipulation n=47 Participants Spinal manipulation in combination with information of clinical findings and advice about back care
Number of Patients on Sick Leave	14 Participants	6 Participants

SECONDARY outcome

Timeframe: twelve months posttreatment

Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: twelve months posttreatment

Outcome measures

Outcome data not reported

Adverse Events

McKenzie Exercises

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Spinal Manipulation

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	McKenzie Exercises n=175 participants at risk McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy	Spinal Manipulation n=175 participants at risk Spinal manipulation in combination with information of clinical findings and advice about back care
Musculoskeletal and connective tissue disorders herniated disc	2.9% 5/175 • During the intervention which had a duration of maximum 3 months Adverse events were collected by registration of patients referred to hospital by a rheumatologist due to signs and symptoms of spinal pathology. It is the judgment of the investigators that they were not likely to be provoked by the treatment itself, since treatment currently was guided by the patient's response of symptoms during treatment.	5.1% 9/175 • During the intervention which had a duration of maximum 3 months Adverse events were collected by registration of patients referred to hospital by a rheumatologist due to signs and symptoms of spinal pathology. It is the judgment of the investigators that they were not likely to be provoked by the treatment itself, since treatment currently was guided by the patient's response of symptoms during treatment.

Additional Information

Tom Petersen

Back and Rehabilitation Center Copenhagen

Phone: +45 35304974

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place