Trial Outcomes & Findings for Low Level Laser Therapy With Physical Therapy for Chronic Musculoskeletal Pain (NCT NCT02785432)
NCT ID: NCT02785432
Last Updated: 2020-07-07
Results Overview
Perceived pain on scale of 0-10 (0=no pain, 10= extremely severe pain). Pain during the previous 24-hour period (best, worst, current) will be measured at T1-T8. The average of 3 scores will be used.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Baseline, 4 week, 8 week
Results posted on
2020-07-07
Participant Flow
Participant milestones
| Measure |
Sham Low Level Laser
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.
Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered.
|
Active Low Level Laser
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Areas for application and contact will otherwise be consistent with the sham group.
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|---|---|---|
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Overall Study
STARTED
|
4
|
7
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Level Laser Therapy With Physical Therapy for Chronic Musculoskeletal Pain
Baseline characteristics by cohort
| Measure |
Sham Low Level Laser
n=4 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.
Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered.
|
Active Low Level Laser
n=7 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Areas for administration and contact will otherwise be consistent with the sham group.
Active low level laser: Active treatment will be delivered using the time, contact, and energy exposures described in the arm description.
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Total
n=11 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
56 years
STANDARD_DEVIATION 15.1 • n=99 Participants
|
64.6 years
STANDARD_DEVIATION 15.8 • n=107 Participants
|
60.3 years
STANDARD_DEVIATION 15.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
7 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Numeric Pain Rating Scale (NPRS)
|
4.0 units on a scale
STANDARD_DEVIATION 1.2 • n=99 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 0.96 • n=107 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 1.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 week, 8 weekPerceived pain on scale of 0-10 (0=no pain, 10= extremely severe pain). Pain during the previous 24-hour period (best, worst, current) will be measured at T1-T8. The average of 3 scores will be used.
Outcome measures
| Measure |
Active Low Level Laser
n=7 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Areas for application and contact will otherwise be consistent with the sham group.
|
Sham Low Level Laser
n=4 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.
Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Baseline
|
3.7 score on a scale
Standard Deviation 0.96
|
4 score on a scale
Standard Deviation 1.2
|
|
Numeric Pain Rating Scale (NPRS)
4 week
|
4.1 score on a scale
Standard Deviation 1.2
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6.1 score on a scale
Standard Deviation 2.0
|
|
Numeric Pain Rating Scale (NPRS)
8 week
|
3.6 score on a scale
Standard Deviation 0.95
|
4.04 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 4 week, 8 weekValid and reliable 11 item assessment of kinesiophobia. Scores range from 11-44, with higher scores indicating greater degrees of kinesiophobia.
Outcome measures
| Measure |
Active Low Level Laser
n=7 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Areas for application and contact will otherwise be consistent with the sham group.
|
Sham Low Level Laser
n=4 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.
Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered.
|
|---|---|---|
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Tampa Scale of Kinesiophobia
Baseline
|
27.5 score on a scale
Standard Deviation 3.8
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33 score on a scale
Standard Deviation 1.1
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Tampa Scale of Kinesiophobia
4 week
|
28.1 score on a scale
Standard Deviation 6.5
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31 score on a scale
Standard Deviation 8.2
|
|
Tampa Scale of Kinesiophobia
8 week
|
22 score on a scale
Standard Deviation 3.5
|
20.2 score on a scale
Standard Deviation 9.2
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SECONDARY outcome
Timeframe: Baseline, 4 week, 8 weekThe Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Active Low Level Laser
n=7 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Areas for application and contact will otherwise be consistent with the sham group.
|
Sham Low Level Laser
n=4 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.
Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index
Baseline
|
9.25 score on a scale
Standard Deviation 5.2
|
9.75 score on a scale
Standard Deviation 3.8
|
|
Pittsburgh Sleep Quality Index
4 week
|
9 score on a scale
Standard Deviation 4.5
|
11.5 score on a scale
Standard Deviation 6.1
|
|
Pittsburgh Sleep Quality Index
8 week
|
8 score on a scale
Standard Deviation 4
|
9.75 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline, 4 week, 8 weekValid and reliable measure of the degree of difficulty with 3 self-selected activities as rated on an 11 point scale. The scores for the three activities are summed to create a total score ranging from 0-30, with higher scores indicating better/normal function.
Outcome measures
| Measure |
Active Low Level Laser
n=7 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Areas for application and contact will otherwise be consistent with the sham group.
|
Sham Low Level Laser
n=4 Participants
Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized.
Sham low level laser: Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered.
|
|---|---|---|
|
Patient Specific Functional Scale
Baseline
|
11.8 score on a scale
Standard Deviation 3.5
|
11.5 score on a scale
Standard Deviation 9.1
|
|
Patient Specific Functional Scale
4 week
|
9.7 score on a scale
Standard Deviation 4.6
|
11.5 score on a scale
Standard Deviation 9.1
|
|
Patient Specific Functional Scale
8 week
|
13.7 score on a scale
Standard Deviation 5.2
|
13.8 score on a scale
Standard Deviation 4.2
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Adverse Events
Sham Low Level Laser
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Low Level Laser
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place