Chronic Pain
Conditions
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
Daily oral GABA for 4 weeks
Daily oral Placebo for 4 weeks
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline | PSQI was administered 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. |
| The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention | PSQI was administered immediately after completing the 4-week 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. |
| Verbal Descriptor Scale (VDS) at Baseline | VDS was administered 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. |
| Verbal Descriptor Scale (VDS) at Post-Intervention | VDS was administered immediately after completing the 4-week 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. |
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline | WOMAC 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-Intervention | WOMAC was administered after completing the 4-week 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale (ESS) at Baseline | 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. |
| Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline | 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. |
| Epworth Sleepiness Scale (ESS) at Post-Intervention | Immediately 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-Intervention | Immediately 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 Baseline | 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. |
| Pain Detect at Post-Intervention | Immediately 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 Baseline | 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. |
| Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention | Immediately 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
| Arm | Count |
|---|---|
| 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 |
| Total | 33 |
Baseline characteristics
| Characteristic | PLACEBO | GABA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 6 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 17 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 16 Participants | 30 Participants |
| Region of Enrollment United States | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 18 |
| other Total, other adverse events | 12 / 15 | 17 / 18 |
| serious Total, serious adverse events | 0 / 15 | 0 / 18 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline | 11.20 Score on scale | Standard Deviation 4.18 |
| GABA | The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Baseline | 9.78 Score on scale | Standard Deviation 3.02 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention | 8.08 Score on scale | Standard Deviation 3.59 |
| GABA | The Pittsburgh Sleep Quality Index (PSQI): PSQI Total Score at Post-Intervention | 7.89 Score on scale | Standard Deviation 3.23 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline | 33.83 Score on scale | Standard Deviation 18.98 |
| GABA | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Baseline | 34.77 Score on scale | Standard Deviation 18.61 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Post-Intervention | 22.92 Score on scale | Standard Deviation 17.98 |
| GABA | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Post-Intervention | 34.87 Score on scale | Standard Deviation 19.41 |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PLACEBO | Verbal Descriptor Scale (VDS) at Baseline | 2.00 Scores on a scale |
| GABA | Verbal Descriptor Scale (VDS) at Baseline | 1.50 Scores on a scale |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PLACEBO | Verbal Descriptor Scale (VDS) at Post-Intervention | 1 Score on scale |
| GABA | Verbal Descriptor Scale (VDS) at Post-Intervention | 1 Score on scale |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Epworth Sleepiness Scale (ESS) at Baseline | 6.67 Score on scale | Standard Deviation 3.03 |
| GABA | Epworth Sleepiness Scale (ESS) at Baseline | 8.56 Score on scale | Standard Deviation 4.13 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Epworth Sleepiness Scale (ESS) at Post-Intervention | 7.08 Score on scale | Standard Deviation 4.44 |
| GABA | Epworth Sleepiness Scale (ESS) at Post-Intervention | 7.56 Score on scale | Standard Deviation 5 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Baseline | 17.54 Score on scale | Standard Deviation 1.28 |
| GABA | Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Baseline | 16.58 Score on scale | Standard Deviation 2.84 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention | 12.60 Score on scale | Standard Deviation 2.7 |
| GABA | Functional Outcomes of Sleep Questionnaire - 10 Items (FOSQ-10) at Post-Intervention | 12.48 Score on scale | Standard Deviation 2.65 |
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Pain Detect at Baseline | 9.23 Score on scale | Standard Deviation 5.7 |
| GABA | Pain Detect at Baseline | 9.39 Score on scale | Standard Deviation 6.89 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Pain Detect at Post-Intervention | 6.54 Score on scale | Standard Deviation 5.17 |
| GABA | Pain Detect at Post-Intervention | 8.33 Score on scale | Standard Deviation 6.27 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline | 2.41 Score on scale | Standard Deviation 1.63 |
| GABA | Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Baseline | 2.21 Score on scale | Standard Deviation 1.62 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-Intervention | 1.43 Score on scale | Standard Deviation 1.14 |
| GABA | Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score at Post-Intervention | 1.77 Score on scale | Standard Deviation 1.36 |