Adjunctive effects of acupressure therapy on pain and quality of life in patients with knee osteoarthritis: an interventional study

Meenu Rani, Lokendra Sharma, Uma Advani, Arun Sharma

1 Department of Pharmacology, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan 302004, India

2 Department of Orthopedics, Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan 302004, India

Abstract

Keywords: Acupoint Therapy; Osteoarthritis, Knee; Quality of Life; Short-form Health Survey; Visual Analog Scale

Knee osteoarthritis (KOA) is a common and chronic type of arthritis among ageing population. This disease slowly affects cartilage, bones and soft tissues and leads to inflammation and pain, which affects the quality of life(QOL)[1-3]. KOA affects many parts of QOL such as physical functioning, emotional behavior, and mental health[4].Pain related to KOA is the main factor responsible for poor QOL[5]. Most common pharmacological treatment for pain management is use of non-steroidal antiinflammatory drugs (NSAIDs), but these drugs are associated with undesirable effects[6]. Due to limitations associated with pharmacological treatment, patients opt for commonly used alternative therapies available for pain management. Popular alternative therapies include therapeutic touch[7], relaxation technique[8], music therapy[9], acupuncture[10]and acupressure. These alternative therapies unlike pharmacological treatment do not produce harmful side effects[11]. Acupressure therapy is an essential part of Chinese medicine. It works similar to acupuncture therapy which mainly focuses on stimulation of acupoints or meridians of the body[12].Instead of a needle, acupressure therapy uses fingers to apply pressure to particular acupoints. Some practitioners also use palms, forearms, elbows and specialized instruments to stimulate acupoints by applying pressure. Stimulation of acupoints circulates vital energy (qi) through the meridian system of the body and balances the flow of energy to rectify the disease.Some practitioners claimed that proper stimulation of acupoints was very effective for managing symptoms of many diseases[13]. There are 366 ordinary acupoints in the body and each acupoint has a specific effect on different part of the body[14].

Acupressure therapy has positive effects in many pain conditions like migraine[15], menstrual pain[16], back pain[17]and various types of joint pain[18]. The present study was planned to check the impact of acupressure treatment on pain and QOL among KOA patients. A number of validated instruments are available for assessment of the QOL among osteoarthritis people[19].In the present study the short-form 36-item health survey (SF-36) questionnaire was used which takes care of multiple health-related dimensions such as physical,social, emotional and general health dimensions. SF-36 reliability for group comparison has been established by Picavet HS,et al[20].

1 Materials

1.1 Participants recruitment and sample size

The present interventional study was conducted to investigate the effect of self-administered acupressure along with pharmacological treatment on pain and QOL among KOA patients. To conduct the study, ethical committee approval (3706/MC/EC/2018 dated on 26/02/2018) was taken from the Sawai Man Singh Medical College and Attached Hospitals. KOA patients were recruited from the orthopedic department of the institute. Duration of the study was 6 months (between May 2018 and November 2018). An 8-week pilot study was conducted to estimate the sample size. Mean difference and standard deviation (±s) of visual analog scale (VAS) obtained from the pilot study were -6.911 and 11.810, respectively. Sample size was calculated using the equation (Figure 1), where the value of variables taken wasZα=3.920,Zβ=0.84,μ1–μ2=-6.911 andS=11.810.

Figure 1. Equation for calculation of sample size

To obtain a significant improvement in VAS score between the intervention and control groups, 45 patients would be necessary in each group to attain 80%power. By assuming a 20% dropout, a total of 100 patients were taken from the outpatient department of orthopedics. Written informed consent was taken from each patient.

1.2 Inclusion criteria

Patients of both gender and between ages 45 and 70;patients having had unilateral knee osteoarthritis since 5-6 months ago; radiographically Kellgren-Lawrence (K-L)grades 2 and 3; patients scored ≥2 points on VAS for pain[21].

1.3 Exclusion criteria

Patients using intra-articular injection for knee osteoarthritis; previously taking acupuncture or acupressure therapy; patients with knee replacement;pregnant women; patients with rheumatoid arthritis or other autoimmune disorders.

1.4 Randomization

All the selected participants were randomly allocated to the intervention group (acupressure plus pharmacological treatment) and the control group(pharmacological treatment). Flipping-coin method [i.e.tails (intervention group) and heads (control group)] was used to randomly divide the patients by an independent researcher (not involved in the trial).

1.5 Blinding

All the investigators of the study were blind to the allocation of patients in each group except the acupuncturist investigator. The acupuncturist investigator trained the patients in acupressure therapy and did not disclose the group allocation until analysis of the study was finished.

1.6 Baseline characteristics

One hundred patients of knee osteoarthritis were selected for current study. Three patients from the intervention group and 1 patient from the control group did not complete the study. The patients aged from 52 to 58 years (mean age 54.7 years). Mean disease durations of KOA were similar between the two groups. Statistically no significant difference was observed in NSAIDs consumption between the two groups. It was reported that participants of both intervention and control groups had similar numbers of comorbidities. Of total enrolled patients, 50.0% of the participants had one or more comorbidities. Most commonly found comorbidities were cardiovascular (30.4%), metabolic (8.0%) and respiratory (15.2%). Majority of patients (57.4%)reported grade 3 on K-L scale. Demographic data of the two groups did not show significant difference at baseline (allP?0.05) as depicted in Table 1.

2 Methods

2.1 Intervention group

Patients of the intervention group received acupressure in combination with pharmacological treatment (NSAIDs). Participants took two acupressure training sessions and one conclusion session. Patients were taught acupressure therapy in their vernacular language by a trained investigator. During the training session, booklets containing complete acupressure procedure with pictorial representation were distributed among participants. Content of the given booklet was checked and approved by trained and qualified acupuncturists. Liangqiu (ST 34), Dubi (ST 35), Zusanli(ST 36), Yinlingquan (SP 9), Xuehai (SP 10) and Yanglingquan (GB 34) around the knee were selected for current study[22]. Patients were instructed to press each acupoint with help of fingers for 2 min twice a day for 5 d in a week. Tenderness indicated accuracy of acupoint.Pressure accuracy indication was obtained by tingling sensation and mild pain at that particular acupoint[23].Patients were advised to record acupressure therapy performance in a given logbook daily.

Table 1. Comparison of the baseline demographic data

First session of training: This training session of acupressure therapy was imparted during the 1st week of study. General procedure of acupressure therapy was taught in this session which focuses on identification of accurate acupoints around the knee and application of pressure. At the end of the initial session, majority of patients got trained in acupressure therapy.

Second training session: This session was carried out during the second week of study. Acupressure therapy procedure was again demonstrated by researcher and doubts of patients regarding the procedure were addressed. Feedback regarding acupressure therapy was recorded.

Concluding session: This session was conducted during the third week. In this session, acupressure therapy adherence was checked by reviewing the logbook response sheet. Patients were asked for any side effects due to acupressure therapy.

2.2 Control group

Patients in the control group received same pharmacological treatment as that in the intervention group only.

2.3 Outcome measurements

General information of patients was gathered by using a questionnaire.

2.3.1 Assessment of health-related QOL

The SF-36 was used for evaluation of QOL. The SF-36 are categorized into 8 domains for assessment of patients’ mental and physical health, which are: physical functioning (PF), bodily pain (BP), general health (GH),social functioning (SF), role limitations due to emotional problems (RE), role limitations due to physical health problems (RP), vitality (VT), and mental health (MH)[20].Scores of each item are summed and then by a Likert scale transformed into a range from 0 (worst health) to 100 (best health)[20].

2.3.2. Assessment of pain

VAS ranged from 0 (no pain) to 10 (worst pain)[21].

2.3.3 Data collection and evaluation

Data of all patients collected and examined at 4 assessment points: at baseline (A0), during training session (A1), follow-up at the 3rd month (A2) and final follow-up at the 6th month of study (A3).

2.3.4 Stratification of patients on the basis of pain improvement

To correlate the pain improvement with healthrelated QOL, patients of both groups were classified into four groups depending on pain improvement from baseline (i.e. ?10% improvement in pain, ≥10% and ?25%improvement in pain, ≥25% and ?50% improvement in pain, and ≥50% improvement in pain).

2.4 Statistical analysis

Normality distribution of data was checked by applying Shapiro-Wilk test. Baseline data of both groups were compared by independentt-test, Chi-square test and Mann-Whitney test. Studentt-test was used to compare data of both groups at each time point.Repeated measure analysis of variance was performed to check the effect of therapy in each group over time.Association between pain improvement and SF-36 subscales was analyzed using multivariate regression analysis. All variables of the study were analyzed by the SPSS version 21.0.P≤0.05 indicated the significance.

3 Results

3.1 Pain (VAS)

Severe pain was experienced among participants in both intervention group (8.99±6.89) and control group(7.98±4.23) at baseline. Participants in the intervention group reported significant reduction in pain from A1 to A3 (P=0.026). Pain reduction among participants in the intervention group was 11.2% (A1), 17.0% (A2) and 40.9% (A3) compared with the baseline score. When comparing pain score at A3 with the baseline, reduction in pain score was significant in the intervention group(P=0.003). The participants in the control group reported 16.0% reduction in pain score from A0 to A3 (P=0.152) as tabulated in Table 2 and Table 3.

3.2 QOL measure (SF-36)

All SF-36 domains except RE in the intervention group revealed significant improvement from baseline to the 6th month follow-up (allP≤0.05). In the intervention group, BP improved by 8.8% and VT domain also improved by 8.0% from baseline. Maximum improvement was observed in scores of MH (11.1%), SF(11.3%) and RP (10.0%) in the intervention group.Participants in the intervention group showed more improvement in QOL as compared with participants in the control group. No significant improvement was showed among participants in the control group when compared from baseline. Please see Table 2 and Table 3.

Table 4 shows the distribution of participants in both groups into four subgroups according to the improvement in VAS score from baseline. Proportionally larger number of patients in the intervention group achieved ≥50% improvement (50.0% versus 32.6%respectively, odd ratio: 2.131), ≥25% improvement(52.2% versus 48.1%, odd ratio: 2.661) and ≥10%improvement (68.1% versus 47.3%, odd ratio: 2.395) in VAS score from A0 to A3 (patients in the intervention group showed more improvement in VAS sco re (P≤0.05).

Table 2. Comparison of mean scores of VAS and SF-36 at different time points ( x ±s, point)

Table 3. Comparison of mean SF-36 and pain scores between the intervention group and the control group from baseline

Table 4. Stratification of patients in both groups based on improvement in VAS from baseline to the 6th month follow-up (case)

3.3 Relationship between QOL and pain improvement

Four groups (based on pain improvement) of participants in the intervention group were similar at baseline for all eight domains of SF-36 questionnaire.Patients of ≥50% improvement in pain demonstrated greater change (improvement) in all eight domains of SF-36 from baseline. On conducting multivariate regression analysis as shown in Table 5, it was observed that all domains of SF-36 were negatively correlated with VAS pain score except BP. Another major observation was that the subscales of SF-36, PF and GH, were strongly related to VAS score.

Table 5. Multivariate regression analysis of the relationship between VAS improvement and SF-36 (%)

4 Discussion

The present study explored the effects of acupressure on the QOL among KOA patients. Knee pain affects the QOL of osteoarthritis patients. QOL and pain were assessed by SF-36 and VAS. Mean age of patients was(54.7±9.8) years. A study conducted among West African osteoarthritis patients reported similar mean age at the onset of osteoarthritis[24]. On analysis it can be concluded that pain and age are the major reasons for poor QOL. All eight domains of SF-36 are affected by KOA.However, Dominick KL,et al[25]compared QOL among rheumatoid arthritis, osteoarthritis and no arthritis patients and observed no significant difference in QOL scores.

Acupressure was effective in addition to pharmacological treatment for pain reduction. Heish LL,et al[26]conducted a study to explore the effect of acupressure in patients with chronic low back pain and observed that acupressure therapy reduced pain.Hjelmstedt A,et al[27]noticed a reduction in labor pain in patients receiving acupressure.

Reduction in pain was related to improvement in QOL among KOA patients[5]. The patients taking acupressure therapy along with pharmacological treatment scored better on pain and all QOL (SF-36) measures as compared with those receiving only pharmacological treatment. Tang L,et al[28]conducted a study to check the effect of acupuncture on KOA and observed a consistent association between pain improvement and QOL measures.

Acupressure decreases pain and makes QOL better by following ways. Firstly, acupressure stimulates relaxation points to make patient feel less pain due to reduction in tension and stress. Secondly, acupressure therapy stimulates meridian system of the body. It is because in acupressure, fingertip is used to manipulate acupoints and fingertips are larger than acupoints. But this mechanism of acupressure therapy has not been mentioned explicitly[29]. Like acupuncture, acupressure also stimulates acupoints and stimulation produces some sedative- and analgesic-like chemicals. Therefore,acupressure therapy decreases pain through mechanical,psychological and physiological ways[30].

In current study, a relationship was reported between pain improvement and QOL improvement. A significant relationship was presented by physical function domain of SF-36 questionnaire and pain improvement. Limited studies have investigated the effect of acupressure therapy on QOL. The present study may shed some light on the effect of mind-body stimulation on QOL.Limitations: First major limitation is that only 6 acupoints around the knee were used. The second limitation is that the study has been carried amongst local population but diverse range of population with larger size will be better for more effective analysis.

5 Conclusion

Current study has assessed the effectiveness of noninvasive acupressure therapy on pain and QOL among knee osteoarthritis patients. Results of the study showed that acupressure together with pharmacological treatment was effective to decrease pain without any side effect. Continuous sessions of acupressure therapy had a positive effect on QOL of osteoarthritis patients.According to the results of current study, it can be concluded that more improvement in pain leads to better functionality and QOL. Therefore, it would prefer to introduce acupressure intervention in health care services because it is a nonaggressive, affordable and safe alternative therapy. To understand the role of acupressure therapy in KOA, in-depth further investigation is required.

Conflict of Interest

The authors certify that they have no affiliations with or involvement in any organization or entity with any financial or non-financial interest in the subject matter or materials discussed in this manuscript.

Statement of Informed Consent

Informed consent was obtained from all individual participants in this study.

Author’s Contribution

Meenu Rani: writing original draft, formal analysis, data curation; Lokendra Sharma: methodology, investigation,supervision; Uma Advani: data curation, review and editing,resources; Arun Sharma: resources, supervision.

Received: 8 July 2020/Accepted: 6 November 2020