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Latent Aging Mechanisms in Pain and Sleep

Sleep, Pain and Aging: Potential Underlying Mechanisms

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04683640
Acronym
LAMPS
Enrollment
33
Registered
2020-12-24
Start date
2021-04-02
Completion date
2024-05-30
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Brief summary

Chronic pain is a serious public health problem in older adults depending on the pain condition, and the capacity to sleep properly changes with age. Given the potential mechanistic role of GABA (gamma-aminobutyric acid) in both conditions, based on our preliminary data, this proposal will determine the effect of oral GABA administration in sleep quality and pain in older adults with chronic pain and sleep disorders as well as to characterize the potential neurobiological mechanisms involved in both illnesses.

Interventions

DIETARY_SUPPLEMENTGABA

Daily oral GABA for 4 weeks

DRUGPlacebo

Daily oral Placebo for 4 weeks

Sponsors

University of Florida
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Thorne HealthTech, Inc
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Older adults 45 years of age or older who experienced pain of at least moderate intensity (\>5/10 pain intensity ratings) on more days than not during the past three months, and who also reported poor sleep quality (\>5 PSQI scores) will be considered for participation.

Exclusion criteria

1. serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder; 2. history of alcohol/drug abuse; 3. Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology and neurological conditions; 4. significant cognitive impairment as evidenced by the Modified Mini-Mental State Examination \[3MS\] score ≤ 77; 5. hospitalizations for mental health reasons in the past year; 6. chronic/current use of narcotic medications; 7. serious systemic (uncontrolled diabetes self-reported HA1C\>7), (uncontrolled hypertension \> 155/90 mm Hg) and rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia, HIV); 8. arterial hypotension; 9. digestive tract diseases; 10. major medical surgery in the past two months, history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures; 11. excessive anxiety regarding protocol procedures; 12. Inability to consent for study participation; 13. Ingestion of sleep medications including those with zolpidem (Ambien and others) and eszopiclone (Lunesta and others); 14. Neuropathic pain medications including anticonvulsants and antidepressants; 15. Allergies or sensitivity to GABA or its ingredients cellulose' gelatin (capsule)' magnesium silicate' vegetable stearate and silica or to the placebo or its ingredients: calcium laurate, hypromellose capsule, magnesium (citrate), microcrystalline cellulose; 16. currently taking barbiturate and benzodiazepine and baclofen; 17. MRI contraindications including large pieces of metal in the body/face/neck and claustrophobia; 18. current cancer diagnosis unless determined no evidence of disease or in remission for at least two years, and 19. pregnancy

Design outcomes

Primary

MeasureTime frameDescription
The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at BaselinePSQI was administered at baselineThe Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.
The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-InterventionPSQI was administered immediately after completing the 4-week interventionThe Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.
Verbal Descriptor Scale (VDS) at BaselineVDS was administered at baselineThe Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.
Verbal Descriptor Scale (VDS) at Post-InterventionVDS was administered immediately after completing the 4-week interventionThe Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at BaselineWOMAC was administered at baseline.The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Post-InterventionWOMAC was administered after completing the 4-week interventionThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.

Secondary

MeasureTime frameDescription
Epworth Sleepiness Scale (ESS) at BaselineBaselineThe Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire that assesses the likelihood of dozing off or falling asleep during common daily activities. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). The total score is calculated by summing the scores across all 8 items, yielding a total range of 0 to 24, with higher scores indicating greater levels of daytime sleepiness.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at BaselineBaselineThe Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) is a validated 22-item self-report instrument that assesses the multidimensional experience of pain. Items are grouped into four subscales-continuous, intermittent, neuropathic, and affective pain-and each item is rated from 0 (no pain) to 10 (worst possible pain) based on pain intensity over the past week. The total score is calculated as the average of all 22 item scores, with higher scores indicating greater pain severity.
Epworth Sleepiness Scale (ESS) at Post-InterventionImmediately post-intervention (4 weeks)The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire that assesses the likelihood of dozing off or falling asleep during common daily activities. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). The total score is calculated by summing the scores across all 8 items, yielding a total range of 0 to 24, with higher scores indicating greater levels of daytime sleepiness.
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-InterventionImmediately post-intervention (4 weeks)The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) is a validated 22-item self-report instrument that assesses the multidimensional experience of pain. Items are grouped into four subscales-continuous, intermittent, neuropathic, and affective pain-and each item is rated from 0 (no pain) to 10 (worst possible pain) based on pain intensity over the past week. The total score is calculated as the average of all 22 item scores, with higher scores indicating greater pain severity.
Pain Detect at BaselineBaselineThe PainDETECT Questionnaire is a validated self-report instrument used to assess the likelihood of a neuropathic pain component in individuals with chronic pain. It includes 9 items that assess pain intensity, pain patterns, and sensory descriptors. The total score ranges from -1 to 38, with higher scores indicating a greater probability of neuropathic pain. A score ≥19 suggests likely neuropathic pain, 13-18 indicates possible neuropathic pain, and ≤12 suggests that neuropathic pain is unlikely.
Pain Detect at Post-InterventionImmediately post-intervention (4 weeks)The PainDETECT Questionnaire is a validated self-report instrument used to assess the likelihood of a neuropathic pain component in individuals with chronic pain. It includes 9 items that assess pain intensity, pain patterns, and sensory descriptors. The total score ranges from -1 to 38, with higher scores indicating a greater probability of neuropathic pain. A score ≥19 suggests likely neuropathic pain, 13-18 indicates possible neuropathic pain, and ≤12 suggests that neuropathic pain is unlikely.
Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at BaselineBaselineThe Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) is a 10-item self-report instrument that assesses the impact of excessive daytime sleepiness on daily functioning across five domains. Each item is rated on a 4-point Likert scale from 1 (extreme difficulty) to 4 (no difficulty). The total score is calculated by averaging items within each domain and summing the domain means. Total scores range from 5 to 20, with higher scores indicating better functional status and less impairment.
Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-InterventionImmediately post-intervention (4 weeks)The Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) is a 10-item self-report instrument that assesses the impact of excessive daytime sleepiness on daily functioning across five domains. Each item is rated on a 4-point Likert scale from 1 (extreme difficulty) to 4 (no difficulty). The total score is calculated by averaging items within each domain and summing the domain means. Total scores range from 5 to 20, with higher scores indicating better functional status and less impairment.

Countries

United States

Participant flow

Pre-assignment details

All participants completed a screening visit and provided written informed consent before randomization. No run-in or washout phases were implemented before treatment initiation.

Participants by arm

ArmCount
PLACEBO
Participants self-administered Placebo (microcrystalline cellulose) capsules (two capsules) daily at home at 08:00 pm for 4 weeks.
15
GABA
Participants self-administered PharmaGABA-250 (gamma-aminobutyric acid 250 mg/cap) 500 mg orally (two 250 mg capsules) daily at home at 08:00 pm for 4 weeks.
18
Total33

Baseline characteristics

CharacteristicPLACEBOGABATotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
12 Participants12 Participants24 Participants
Age, Categorical
Between 18 and 65 years
3 Participants6 Participants9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants17 Participants32 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
14 Participants16 Participants30 Participants
Region of Enrollment
United States
15 Participants18 Participants33 Participants
Sex: Female, Male
Female
13 Participants13 Participants26 Participants
Sex: Female, Male
Male
2 Participants5 Participants7 Participants
The Pittsburgh Sleep Quality Index (PSQI)11.20 Units on a scale (0-21).
STANDARD_DEVIATION 4.18
9.78 Units on a scale (0-21).
STANDARD_DEVIATION 3.02
10.43 Units on a scale (0-21).
STANDARD_DEVIATION 3.59

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 18
other
Total, other adverse events
12 / 1517 / 18
serious
Total, serious adverse events
0 / 150 / 18

Outcome results

Primary

The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline

The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.

Time frame: PSQI was administered at baseline

Population: Baseline characteristics for the Pittsburgh Sleep Quality Index (PSQI) are reported for participants who completed the baseline assessment and had complete PSQI data.

ArmMeasureValue (MEAN)Dispersion
PLACEBOThe Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline11.20 Score on scaleStandard Deviation 4.18
GABAThe Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline9.78 Score on scaleStandard Deviation 3.02
Primary

The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention

The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over the past month. It consists of 19 items grouped into seven components. Each component is scored from 0 to 3, and the component scores are summed to yield a global total score ranging from 0 to 21. Higher scores indicate worse sleep quality. A total score greater than 5 is typically used to distinguish poor sleepers from good sleepers.

Time frame: PSQI was administered immediately after completing the 4-week intervention

Population: The number of participants analyzed post-intervention differs from the baseline assessment due to missing data. Two participants in Group A did not complete the PSQI at the post-intervention time point and were therefore excluded from the post-intervention analysis. All other participants included had complete data.

ArmMeasureValue (MEAN)Dispersion
PLACEBOThe Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention8.08 Score on scaleStandard Deviation 3.59
GABAThe Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention7.89 Score on scaleStandard Deviation 3.23
Primary

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.

Time frame: WOMAC was administered at baseline.

Population: The analysis population for the WOMAC at baseline includes all participants who were assigned to Group A (n=15) and Group B (n=18), as all completed the baseline assessment.

ArmMeasureValue (MEAN)Dispersion
PLACEBOThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline33.83 Score on scaleStandard Deviation 18.98
GABAThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline34.77 Score on scaleStandard Deviation 18.61
Primary

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Post-Intervention

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated self-report questionnaire that assesses pain, stiffness, and physical function in individuals with musculoskeletal conditions. It includes 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme), producing subscale scores and a total score. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse symptoms and functional limitations.

Time frame: WOMAC was administered after completing the 4-week intervention

ArmMeasureValue (MEAN)Dispersion
PLACEBOThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Post-Intervention22.92 Score on scaleStandard Deviation 17.98
GABAThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Post-Intervention34.87 Score on scaleStandard Deviation 19.41
Primary

Verbal Descriptor Scale (VDS) at Baseline

The Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.

Time frame: VDS was administered at baseline

Population: The analysis population for the Verbal Descriptor Scale (VDS) at baseline includes all participants who were assigned to Group A (n=15) and Group B (n=18), as all completed the baseline assessment.

ArmMeasureValue (MEDIAN)
PLACEBOVerbal Descriptor Scale (VDS) at Baseline2.00 Scores on a scale
GABAVerbal Descriptor Scale (VDS) at Baseline1.50 Scores on a scale
Primary

Verbal Descriptor Scale (VDS) at Post-Intervention

The Verbal Descriptor Scale (VDS) is a validated self-report measure of pain intensity, commonly used in older adults. Participants are asked to select the descriptor that best represents their current pain level from six options: No pain, Mild, Moderate, Severe, Very severe, and Worst possible pain. Each descriptor corresponds to a numeric value from 0 to 5, with higher scores indicating greater pain intensity.

Time frame: VDS was administered immediately after completing the 4-week intervention

Population: The number of participants analyzed post-intervention differs from the baseline assessment due to missing data. Two participants in Group A did not complete the VDS at the post-intervention time point and were therefore excluded from the post-intervention analysis. All other participants included had complete data.

ArmMeasureValue (MEDIAN)
PLACEBOVerbal Descriptor Scale (VDS) at Post-Intervention1 Score on scale
GABAVerbal Descriptor Scale (VDS) at Post-Intervention1 Score on scale
Secondary

Epworth Sleepiness Scale (ESS) at Baseline

The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire that assesses the likelihood of dozing off or falling asleep during common daily activities. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). The total score is calculated by summing the scores across all 8 items, yielding a total range of 0 to 24, with higher scores indicating greater levels of daytime sleepiness.

Time frame: Baseline

Population: The number of participants analyzed differs from the number of participants assigned to the group due to missing data. Three participants in Group A, and two in Group B, did not complete the ESS at the baseline time point and were, therefore, excluded from the baseline analysis. All other participants included had complete data.

ArmMeasureValue (MEAN)Dispersion
PLACEBOEpworth Sleepiness Scale (ESS) at Baseline6.67 Score on scaleStandard Deviation 3.03
GABAEpworth Sleepiness Scale (ESS) at Baseline8.56 Score on scaleStandard Deviation 4.13
Secondary

Epworth Sleepiness Scale (ESS) at Post-Intervention

The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire that assesses the likelihood of dozing off or falling asleep during common daily activities. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). The total score is calculated by summing the scores across all 8 items, yielding a total range of 0 to 24, with higher scores indicating greater levels of daytime sleepiness.

Time frame: Immediately post-intervention (4 weeks)

Population: The number of participants analyzed differs from the number of participants assigned to the group due to missing data. Three participants in Group A did not complete the ESS at the post-intervention time point and were, therefore, excluded from the post-intervention analysis. All other participants included had complete data.

ArmMeasureValue (MEAN)Dispersion
PLACEBOEpworth Sleepiness Scale (ESS) at Post-Intervention7.08 Score on scaleStandard Deviation 4.44
GABAEpworth Sleepiness Scale (ESS) at Post-Intervention7.56 Score on scaleStandard Deviation 5
Secondary

Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Baseline

The Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) is a 10-item self-report instrument that assesses the impact of excessive daytime sleepiness on daily functioning across five domains. Each item is rated on a 4-point Likert scale from 1 (extreme difficulty) to 4 (no difficulty). The total score is calculated by averaging items within each domain and summing the domain means. Total scores range from 5 to 20, with higher scores indicating better functional status and less impairment.

Time frame: Baseline

Population: The number of participants analyzed differs from the number of participants assigned to the group due to missing data. Three participants in Group A, and two in Group B, did not complete the FOSQ-10 at the baseline time point and were, therefore, excluded from the baseline analysis. All other participants included had complete data.

ArmMeasureValue (MEAN)Dispersion
PLACEBOFunctional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Baseline17.54 Score on scaleStandard Deviation 1.28
GABAFunctional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Baseline16.58 Score on scaleStandard Deviation 2.84
Secondary

Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention

The Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) is a 10-item self-report instrument that assesses the impact of excessive daytime sleepiness on daily functioning across five domains. Each item is rated on a 4-point Likert scale from 1 (extreme difficulty) to 4 (no difficulty). The total score is calculated by averaging items within each domain and summing the domain means. Total scores range from 5 to 20, with higher scores indicating better functional status and less impairment.

Time frame: Immediately post-intervention (4 weeks)

Population: The number of participants analyzed post-intervention differs from the baseline assessment due to missing data. Two participants in Group A did not complete the FOSQ-10 at the post-intervention time point and were therefore excluded from the post-intervention analysis. All other participants included had complete data.

ArmMeasureValue (MEAN)Dispersion
PLACEBOFunctional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention12.60 Score on scaleStandard Deviation 2.7
GABAFunctional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention12.48 Score on scaleStandard Deviation 2.65
Secondary

Pain Detect at Baseline

The PainDETECT Questionnaire is a validated self-report instrument used to assess the likelihood of a neuropathic pain component in individuals with chronic pain. It includes 9 items that assess pain intensity, pain patterns, and sensory descriptors. The total score ranges from -1 to 38, with higher scores indicating a greater probability of neuropathic pain. A score ≥19 suggests likely neuropathic pain, 13-18 indicates possible neuropathic pain, and ≤12 suggests that neuropathic pain is unlikely.

Time frame: Baseline

ArmMeasureValue (MEDIAN)Dispersion
PLACEBOPain Detect at Baseline9.23 Score on scaleStandard Deviation 5.7
GABAPain Detect at Baseline9.39 Score on scaleStandard Deviation 6.89
Secondary

Pain Detect at Post-Intervention

The PainDETECT Questionnaire is a validated self-report instrument used to assess the likelihood of a neuropathic pain component in individuals with chronic pain. It includes 9 items that assess pain intensity, pain patterns, and sensory descriptors. The total score ranges from -1 to 38, with higher scores indicating a greater probability of neuropathic pain. A score ≥19 suggests likely neuropathic pain, 13-18 indicates possible neuropathic pain, and ≤12 suggests that neuropathic pain is unlikely.

Time frame: Immediately post-intervention (4 weeks)

Population: The number of participants analyzed post-intervention differs from the baseline assessment due to missing data. Two participants in Group A did not complete the Pain Detect at the post-intervention time point and were, therefore, excluded from the post-intervention analysis. All other participants included had complete data.

ArmMeasureValue (MEAN)Dispersion
PLACEBOPain Detect at Post-Intervention6.54 Score on scaleStandard Deviation 5.17
GABAPain Detect at Post-Intervention8.33 Score on scaleStandard Deviation 6.27
Secondary

Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline

The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) is a validated 22-item self-report instrument that assesses the multidimensional experience of pain. Items are grouped into four subscales-continuous, intermittent, neuropathic, and affective pain-and each item is rated from 0 (no pain) to 10 (worst possible pain) based on pain intensity over the past week. The total score is calculated as the average of all 22 item scores, with higher scores indicating greater pain severity.

Time frame: Baseline

Population: The number of participants analyzed differs from the number of participants assigned to the group due to missing data. One participant in Group B did not complete the SF-MPQ-2 at baseline time point and was, therefore, excluded from the baseline analysis. All other participants included had complete data.

ArmMeasureValue (MEAN)Dispersion
PLACEBOShort-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline2.41 Score on scaleStandard Deviation 1.63
GABAShort-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline2.21 Score on scaleStandard Deviation 1.62
Secondary

Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-Intervention

The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) is a validated 22-item self-report instrument that assesses the multidimensional experience of pain. Items are grouped into four subscales-continuous, intermittent, neuropathic, and affective pain-and each item is rated from 0 (no pain) to 10 (worst possible pain) based on pain intensity over the past week. The total score is calculated as the average of all 22 item scores, with higher scores indicating greater pain severity.

Time frame: Immediately post-intervention (4 weeks)

Population: The number of participants analyzed post-intervention differs from the baseline assessment due to missing data. Two participants in Group A did not complete the SF-MPQ-2 at the post-intervention time point and were, therefore, excluded from the post-intervention analysis. All other participants included had complete data.

ArmMeasureValue (MEAN)Dispersion
PLACEBOShort-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-Intervention1.43 Score on scaleStandard Deviation 1.14
GABAShort-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-Intervention1.77 Score on scaleStandard Deviation 1.36

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026