Trial Outcomes & Findings for Spinal Pain and Autonomic Responses to Chiropractic Care (NCT NCT03576846)

NCT ID: NCT03576846

Last Updated: 2025-12-24

Results Overview

The variation in beat-to-beat heart rate is an indicator of parasympathetic and sympathetic modulation of the heart rhythm. It is measured as the time between two R-waves on the ECG and measured in ms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 131 participants
• Primary outcome timeframe: 2 weeks, the change is reported between baseline-2 weeks
• Results posted on: 2025-12-24

Participant Flow

Participant milestones

Measure	Intervention Stretching and Spinal Manipulative Therapy Stretching and Spinal manipulative therapy: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy	Comparator Stretching Stretching: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
Overall Study STARTED	66	65
Overall Study Responders	27	26
Overall Study Non-responders	27	25
Overall Study COMPLETED	54	41
Overall Study NOT COMPLETED	12	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=66 Participants Stretching and Spinal Manipulative Therapy Stretching and Spinal manipulative therapy: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy	Comparator n=65 Participants Stretching Stretching: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.	Total n=131 Participants Total of all reporting groups
Age, Continuous	57 Years STANDARD_DEVIATION 14 • n=66 Participants	57.5 Years STANDARD_DEVIATION 36 • n=65 Participants	57.2 Years STANDARD_DEVIATION 13.8 • n=131 Participants
Sex: Female, Male Female	37 Participants n=66 Participants	36 Participants n=65 Participants	73 Participants n=131 Participants
Sex: Female, Male Male	29 Participants n=66 Participants	29 Participants n=65 Participants	58 Participants n=131 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Heart rate variability	27 ms STANDARD_DEVIATION 29 • n=62 Participants • A few participants did not have HRV measurements of sufficient quality, and their measurements had to be excluded	29 ms STANDARD_DEVIATION 21 • n=58 Participants • A few participants did not have HRV measurements of sufficient quality, and their measurements had to be excluded	28 ms STANDARD_DEVIATION 25 • n=120 Participants • A few participants did not have HRV measurements of sufficient quality, and their measurements had to be excluded

PRIMARY outcome

Timeframe: 2 weeks, the change is reported between baseline-2 weeks

The variation in beat-to-beat heart rate is an indicator of parasympathetic and sympathetic modulation of the heart rhythm. It is measured as the time between two R-waves on the ECG and measured in ms.

Outcome measures

Measure	Intervention n=62 Participants Stretching and Spinal Manipulative Therapy Stretching and Spinal manipulative therapy: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy	Comparator n=61 Participants Stretching Stretching: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
Change in Heart Rate Variability	843 ms Standard Deviation 129	887 ms Standard Deviation 138

SECONDARY outcome

Timeframe: The test is done at baseline and again at 2 weeks, and the outcome is the difference between these two scores

Population: In this analysis, the original study arms were not used, and the participants were treated as one cohort.

Conditioned Pain Modulation is assessed using a thumb clamp and a cold pressor test. Pain is rated on the Numeric Rating Scale, ranging from 10 (unbearable pain) to 0 (no pain). The outcome is the difference between these two measurements.

Outcome measures

Measure	Intervention n=53 Participants Stretching and Spinal Manipulative Therapy Stretching and Spinal manipulative therapy: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy	Comparator n=52 Participants Stretching Stretching: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
Change in Conditioned Pain Modulation, Measured as the Difference in Pain Intensity Between Two Conditions .	-3.3 NRS change score Standard Deviation 0.2	0.2 NRS change score Standard Deviation 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks, pain intensity is assessed at Baseline and after 2 weeks, the outcome is the difference between them.

Population: This is an intention-to-treat analysis. Participants are analyzed according to the arm in which they were randomized.

Self-reported, using the Numeric Rating Scale (0-10). High scores indicate more severe pain. The outcome is the difference between the scores measured at baseline at at two weeks.

Outcome measures

Measure	Intervention n=65 Participants Stretching and Spinal Manipulative Therapy Stretching and Spinal manipulative therapy: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy	Comparator n=64 Participants Stretching Stretching: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
Change in Pain Intensity	1.1 score on a scale Standard Deviation 2.085	1.1 score on a scale Standard Deviation 2.101

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Population: The disability score is based on the instrument Neck Disability Index, and the change is the difference between the last and first measurement, 2 weeks apart

Neck Disability Index (10 questions, answer options 1-6, summary score, higher score indicating higher disabiity), reported at baseline and at 2 weeks follow up. The measure is the difference between these two scores

Outcome measures

Measure	Intervention n=57 Participants Stretching and Spinal Manipulative Therapy Stretching and Spinal manipulative therapy: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy	Comparator n=58 Participants Stretching Stretching: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
Change in Disability Score	-2.1 score on a scale Standard Deviation 4.58	-1.9 score on a scale Standard Deviation 4.21

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week

Population: Description and count of side-effects

Description and count of common side effects, data collected through a single question using text messages.

Thus, the participants described their side-effects, which were categorized and counted.

Outcome measures

Measure	Intervention n=66 Participants Stretching and Spinal Manipulative Therapy Stretching and Spinal manipulative therapy: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy	Comparator n=65 Participants Stretching Stretching: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
Common Side-effects	3 Participants	1 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Comparator

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=66 participants at risk Stretching and Spinal Manipulative Therapy Stretching and Spinal manipulative therapy: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy	Comparator n=65 participants at risk Stretching Stretching: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
Musculoskeletal and connective tissue disorders Minor	4.5% 3/66 • Number of events 3 • The participants were asked to report adverse events 1 day after the first treatment was administered. Subjects were asked to report any adverse reactions to the first treatment through a text message, i.e. increased tenderness or fatigue in the neck, answered with an NRS-11 scale anchored by the descriptors 'No reaction' (0) and 'Worst reaction imaginable'	1.5% 1/65 • Number of events 1 • The participants were asked to report adverse events 1 day after the first treatment was administered. Subjects were asked to report any adverse reactions to the first treatment through a text message, i.e. increased tenderness or fatigue in the neck, answered with an NRS-11 scale anchored by the descriptors 'No reaction' (0) and 'Worst reaction imaginable'

Additional Information

Ass professor Iben Axén

Karolinska Institutet

Phone: +46704400618

Email: iben.axen@ki.se

Results disclosure agreements

• Principal investigator is a sponsor employee The agreement stipulates that the funder has no say in the analysis, interpretation, publication or communication of the results.
• Publication restrictions are in place

Restriction type: OTHER