Trial Outcomes & Findings for Preventive Care of Chronic Cervical Pain and Disabilities (NCT NCT00566930)

NCT ID: NCT00566930

Last Updated: 2012-09-28

Results Overview

Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

117 participants

Primary outcome timeframe

Up to 10 months

Results posted on

2012-09-28

Participant Flow

chripractic clinic

117 participants were initially recruited. Following the initial clinical assessment, 98 met all inclusion criteria and were assigned to one of the three groups. 19 participants were excluded because they did not met all inclusion criteria (most common reason was that their neck pain could not be diagnosed as a common non specific neck pain).

Participant milestones

Participant milestones
Measure
Control
control group with no treatment only regular assessment appointments
Spinal Manipulation
spinal manipulation
Spinal Manipulation and Exercises
Spinal manipulation + exercises
Overall Study
STARTED
29
36
33
Overall Study
COMPLETED
27
32
32
Overall Study
NOT COMPLETED
2
4
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventive Care of Chronic Cervical Pain and Disabilities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=29 Participants
control group with no treatment only regular assessment appointments
Spinal Manipulation
n=36 Participants
spinal manipulation
Spinal Manipulation and Exercises
n=33 Participants
Spinal manipulation + exercises
Total
n=98 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Age, Categorical
Between 18 and 65 years
29 Participants
n=93 Participants
36 Participants
n=4 Participants
33 Participants
n=27 Participants
98 Participants
n=483 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Age Continuous
43 years
STANDARD_DEVIATION 11 • n=93 Participants
37 years
STANDARD_DEVIATION 11 • n=4 Participants
37 years
STANDARD_DEVIATION 11 • n=27 Participants
39 years
STANDARD_DEVIATION 11 • n=483 Participants
Sex: Female, Male
Female
23 Participants
n=93 Participants
14 Participants
n=4 Participants
14 Participants
n=27 Participants
51 Participants
n=483 Participants
Sex: Female, Male
Male
6 Participants
n=93 Participants
22 Participants
n=4 Participants
19 Participants
n=27 Participants
47 Participants
n=483 Participants
Region of Enrollment
Canada
29 participants
n=93 Participants
36 participants
n=4 Participants
33 participants
n=27 Participants
98 participants
n=483 Participants

PRIMARY outcome

Timeframe: Up to 10 months

Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)

Outcome measures

Outcome measures
Measure
Control
n=29 Participants
control group with no treatment only regular assessment appointments
Spinal Manipulation
n=36 Participants
spinal manipulation
Spinal Manipulation and Exercises
n=33 Participants
Spinal manipulation + exercises
Neck Pain
3.8 cm
Standard Deviation 1.9
3.3 cm
Standard Deviation 1.7
3.4 cm
Standard Deviation 1.7

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Spinal Manipulation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Spinal Manipulation and Exercises

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Martin Descarreaux

UQTR

Phone: 819 376-5011

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place