Background: Plant extracts with analgesic properties are seldom considered for treatment of acute musculoskeletal pain due to delay in onset of analgesia. Turmeric (Curcuma longa) and boswellia (Boswellia serrata) extracts are well-studied antiinflammatory compounds gaining in popularity and used as an alternative to conventional treatments for musculoskeletal pain. This study analyzed the analgesic effect of a formulation of turmeric and boswellia extracts in sesame oil (Rhuleave-K, TBF) in reducing exercise-induced acute musculoskeletal pain in healthy participants.Methods: In this randomized double-blinded placebo-controlled, single-dose, single-day, multicentre study, a total of 232 participants (TBF n = 116; placebo n = 116) having moderate-to-severe exercise-induced acute musculoskeletal pain were randomized in an allocation concealed 1:1 ratio to receive a single dose of 1000 mg of TBF or placebo. The outcome measures were numerical rating scale (NRS), categorical pain relief scale (PRS), onset of analgesia, and short form of McGill questionnaire (SF-MPQ). NRS and PRS were measured from predose to every 30 minutes interval of postdose up to 6 hours at rest, with movement and applying pressure on the affected part. The onset of analgesia was measured from the time of dosage and censored at 6 hours of postdose. The sum of pain intensity difference (SPID6) and total pain relief (TOTPAR6) at 6 hours was, respectively, analyzed from NRS and PRS scores.Results: TBF showed a significant reduction in pain intensity (SPID6 rest ) with 97.85% improvement in cumulative responder analysis compared with 2.46% in placebo. The onset of pain relief was fast and highly significant in the TBF group with 99% of participants having a mean perceptible pain relief at 68.5 minutes (95% confidence interval, 59.5-77.4) and 96% of participants having a mean meaningful pain relief at 191.6 minutes (95% confidence interval, 176.7-206.4) compared to the placebo group. Highly significant and continuous improvement in pain relief was observed in the TBF group with 93% of participants having ≥ 50% of maximum TOTPAR6 with a number needed to treat of 1.1 at rest. Conclusion:Exercise-induced acute musculoskeletal pain can be effectively relieved by TBF (Rhuleave-K) in about 3 hours signifying its strong analgesic activity.Abbreviations: MPR = meaningful pain relief, MSDs = musculoskeletal disorders, NNT = number needed to treat, NRS = numerical rating scale, PID = pain intensity difference, PPR = perceptible pain relief, RMLT = restricted mean survival time lost, RMST = restricted mean survival time, SDD = smallest detectable difference, SF-MPQ = short form of McGill pain questionnaire, SPID = sum of pain intensity difference, SRM = standardized response mean, TOTPAR = total pain relief.
Acute pain in different parts of the body viz., head and neck, trunk, upper and lower limbs tend to be perceived differently. A randomized double-blinded placebo-controlled study was conducted on 232 healthy participants with acute musculoskeletal pain. The participants were randomized in a 1:1 ratio to receive a single dose of 1000 mg of Curcuma longa and Boswellia serrata extract formulation (CBF, Rhuleave-K) or placebo. The participants were categorized according to the location of the pain- head and neck, upper limb, lower limb, trunk, and general body following exercise. Pain intensity was analyzed using a numerical rating scale (NRS) at intervals of 30 minutes up to 6 hours. NRS was taken at rest, on movement and applying pressure on the affected part. The perceptible pain relief (PPR) and meaningful pain relief (PPR) was assessed using the double stopwatch method. In the CBF group, the pain intensity in the head and neck region had a 100% reduction at rest, on movement and pressure (p=0.02) and in generalized body pain, 100% at rest and movement and 97% reduction on applying pressure (p=0.06). Pain in the upper limb, trunk, and lower limb respectively showed a significant reduction of 99%, 97%, and 97% (p<0.001) in the CBF group at rest, on movement and pressure whereas the placebo group showed negligent change. The PPR and MPR obtained at head and neck (40, 160 min), upper limb (52, 167 min), trunk (75, 216 min), lower limb (74, 175 min), and generalized body pain (75, 240 min) in CBF group were significantly faster than the placebo group (p<0.001). CBF can be recommended as a fast-acting alternative to current therapies for acute musculoskeletal pain affecting head and neck, upper and lower limbs, trunk, and general body pain.
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