Latent Aging Mechanisms in Pain and Sleep

Phase 2

Completed

Conditions: Chronic Pain

Interventions: Dietary Supplement: GABA
Drug: Placebo

Registration Number: NCT04683640

Lead Sponsor: University of Florida

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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

serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder;
history of alcohol/drug abuse;
Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology and neurological conditions;
significant cognitive impairment as evidenced by the Modified Mini-Mental State Examination [3MS] score ≤ 77;
hospitalizations for mental health reasons in the past year;
chronic/current use of narcotic medications;
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);
arterial hypotension;
digestive tract diseases;
major medical surgery in the past two months, history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures;
excessive anxiety regarding protocol procedures;
Inability to consent for study participation;
Ingestion of sleep medications including those with zolpidem (Ambien and others) and eszopiclone (Lunesta and others);
Neuropathic pain medications including anticonvulsants and antidepressants;
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;
currently taking barbiturate and benzodiazepine and baclofen;
MRI contraindications including large pieces of metal in the body/face/neck and claustrophobia;
current cancer diagnosis unless determined no evidence of disease or in remission for at least two years, and
pregnancy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily Oral GABA	GABA	You will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks
Daily Placebo	Placebo	You will take, by mouth, 2 pills of Placebo daily at home for 4 weeks

Primary Outcome Measures

Name	Time	Method
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.
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.
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 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 Outcome Measures

Name	Time	Method
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.
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.
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.
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 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.
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.
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.